Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2018 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2019 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Sep 27, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 20, 2017 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2017 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 16, 2023 | I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 002 RX (4MG/3ML (1.34MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 2, 2022 | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 2, 2022 | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 2, 2022 | |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jun 30, 2023 | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | May 23, 2024 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Sep 24, 2020 | Aug 13, 2025 | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Oct 20, 2025 | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jan 20, 2026 | |
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Mar 20, 2026 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Jul 17, 2026 | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 002: Sep 21, 2021 | Jul 17, 2026 | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 002: Dec 21, 2020 | Aug 3, 2026 | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 27, 2027 | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Sep 29, 2027 | |
| Pat. No. 8129343 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Dec 5, 2031 | U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 002: Dec 21, 2020 | Feb 1, 2032 | |
| Pat. No. 10335462 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 24, 2020 | Jun 21, 2033 | U-2580: A method of treating Type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 16, 2023 | I-822: Reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease |
| Exclusivity Code: NCE - New chemical entity | Dec 5, 2022 |
BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: Blood Glucose Regulators:Glycemic Agents == antihypoglycemic agent == gastrointestinal motility inhibitor
NDA Applicant: ELI LILLY AND CO NDA No.: 210134 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6938798 DP* Fluid or powdery product dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2019 | Jan 3, 2022 | |
| Pat. No. 10213487 DP* Nasal powder formulation for treatment of hypoglycemia Claim Types: Formulation; Process; Device; Method of use Pat. Sub. Date(s): 001: Aug 23, 2019 | Feb 16, 2036 | U-2604: Treatment of severe hypoglycemia in patients with diabetes |
| Pat. No. 10894133 DP* Device for dispensing a fluid product Claim Types: Device Pat. Sub. Date(s): 001: Feb 10, 2021 | Jan 3, 2038 | |
| Pat. No. 10765602 DP* Medication delivery systems and methods Claim Types: Device; Method of administration; Container Pat. Sub. Date(s): 001: Oct 8, 2020 | Sep 23, 2039 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jul 24, 2022 |
CLOBEX (SHAMPOO) (TOPICAL) CLOBETASOL PROPIONATE [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == corticosteroid
NDA Applicant: GALDERMA LABS NDA No.: 021644 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7700081 Foaming compositions for hair care Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 3, 2022 | U-1044: Topical treatment of scalp psoriasis |
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 9, 2022 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 1, 2024 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 28, 2025 | |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 24, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 4, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 12, 2029 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | May 14, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 12, 2019 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP) |
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED |
ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021393 Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8883849 Treatment of sleep disturbances Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014 | Jan 17, 2022 | U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient |
| Pat. No. 9155718 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2015 | Jan 17, 2022 |
ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents == pyridone
NDA Applicant: GENENTECH INC NDA No.: 208780 Prod. No.: 001 RX (267MG); 003 RX (801MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 25, 2022 | |
| Pat. No. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Sep 22, 2026 | U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis |
| Pat. No. 7767700 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration; Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Dec 18, 2027 | U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 8420674 Method of providing pirfenidone therapy to a patient Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Dec 18, 2027 | U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2077: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400 mg/day dose then full day daily dose in treatment of IPF U-2078: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF |
| Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF |
| Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF |
| Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Apr 22, 2029 | U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day |
| Pat. No. 7816383 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone |
| Pat. No. 7910610 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone |
| Pat. No. 8013002 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine |
| Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy |
| Pat. No. 8318780 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6 U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone |
| Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Jan 8, 2030 | U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy |
| Pat. No. 8778947 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Aug 30, 2033 | U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder |
| Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 25, 2019 | Mar 28, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 15, 2021 | ODE-77: Treatment of idiopathic pulmonary fibrosis |
ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents == pyridone
NDA Applicant: GENENTECH INC NDA No.: 208780 Prod. No.: 002 DISC (534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561217 DP* Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 25, 2022 | |
| Pat. No. 8383150 DP* Granulate formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 8, 2018 | Sep 22, 2026 | U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis |
| Pat. No. 7767700 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration; Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Dec 18, 2027 | U-2080: Pirfenidone dose escalation regimen for treatment of IPF as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 8420674 Method of providing pirfenidone therapy to a patient Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Dec 18, 2027 | U-2079: Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for days 8-14 of the regimen, and 2403 mg/day for at least day 15 of the regimen |
| Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2269: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-2400mg/day dose then full daily dose in treatment of IPF U-2270: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, then sub-2400mg/day dose, then full daily dose in treatment of IPF |
| Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2072: Full daily dosing following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2073: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering full daily dose in treatment of IPF U-2074: Dosing 1602 mg/day pirfenidone following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2075: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits followed by administering 1602 mg/day in treatment of IPF U-2076: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering 801 mg/day followed by administering 1602 mg/day in treatment of IPF U-2083: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by 801 mg/day, dose, then 1602 mg/day in treatment of IPF |
| Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2055: Dosing of at least 1600 mg/day following grade 2 liver abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2056: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-1600 mg/day, following by administering at least 1600 mg/day in treatment of IPF U-2057: Dosing 2403 mg/day pirfenidone following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration in treatment of IPF U-2058: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by administering sub-2400mg/day dose, followed by administering 2403mg/day in treatment of IPF U-2059: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose in treatment of IPF U-2060: Dosage modification following grade 2 abnormality in biomarker ast and/or alt after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then at least 1600mg/day in treatment of IPF U-2061: Dosing of at least 1600 mg/day following grade 2 abnormality in liver function biomarker after pirfenidone administration in treatment of IPF U-2062: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by administering sub-1600 mg/day dose, followed by administering at least 1600 mg/day dose in treatment of IPF U-2063: Dosage modification following grade 2 abnormality in liver function biomarker after pirfenidone administration, by discontinuing pirfenidone until biomarkers are within normal limits, followed by administering at least 1600 mg/day in treatment of IPF |
| Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Apr 22, 2029 | U-2064: Dosing at least 1602 mg/day following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2065: Full daily dosing following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration U-2066: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering sub-2400 mg/day dose, followed by full daily dose U-2067: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone, followed by administering at least 1602 mg/day U-2068: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, followed by full daily dose U-2069: Dosage modification following grade 2 abnormality in liver function biomarker alt or ast after pirfenidone administration, by administering a sub-1600 mg/day dose, followed by administering at least 1602 mg/day U-2070: Dosage modification following grade 2 abnormality in biomarker alt or ast after pirfenidone administration, by discontinuing pirfenidone until biomarkers of liver function are within normal limits, then sub-1600 mg/day, then at least 1602 mg/day |
| Pat. No. 7816383 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2042: Discontinuing administration of fluvoxamine to avoid drug interactions with pirfenidone and then administering pirfenidone U-2050: Administering pirfenidone while avoiding co-administration of fluvoxamine to avoid drug interactions with pirfenidone |
| Pat. No. 7910610 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2048: Administering pirfenidone while avoiding co-administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone U-2049: Discontinuing administration of a strong CYP1A2 inhibitor to avoid drug interactions with pirfenidone and then administering pirfenidone |
| Pat. No. 8013002 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2047: Administering pirfenidone concurrently with fluvoxamine, the pirfenidone at a dose of about 801 mg/day to reduce drug interactions with fluvoxamine U-2082: Modifying pirfenidone administration from a dose of about 2400 mg/day downward by about 1600 mg/day while co-administering fluvoxamine to reduce drug interactions with fluvoxamine |
| Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2054: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2 to avoid reduced pirfenidone efficacy U-2268: Discontinuing a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8318780 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2046: Administering pirfenidone while avoiding concomitant use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, AND CYP2D6 U-2081: Discontinuing use of a CYP1A2 inhibitor that is a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme selected from CYP2C9, CYP2C19, and CYP2D6 and then administering pirfenidone |
| Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2051: Discontinuing smoking to avoid reduced pirfenidone efficacy and then administering pirfenidone U-2052: Discontinuing administration of a strong CYP1A2 inducer to avoid reduced pirfenidone efficacy and then administering pirfenidone |
| Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 8, 2018 | Jan 8, 2030 | U-2053: Administering pirfenidone while avoiding concomitant administration of a strong inducer of CYP1A2, including cigarette smoke, to avoid reduced pirfenidone efficacy |
| Pat. No. 8778947 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 8, 2018 | Aug 30, 2033 | U-2044: Dose reduction of pirfenidone by about one half during concurrent administration of ciprofloxacin at a dose of 750 mg twice daily (1500 mg/day) to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder U-2045: Administration of pirfenidone and avoiding concurrent administration of ciprofloxacin at a dose of 750 mg to reduce drug interactions in treatment of a fibrotic, inflammatory, or autoimmune disorder |
| Pat. No. 10188637 DP* Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 25, 2019 | Mar 28, 2037 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 15, 2021 | ODE-77: Treatment of idiopathic pulmonary fibrosis |
ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 DISC (1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 6977257 DP* Aripiprazole oral solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 24, 2022 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 202971 Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8993761 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 28, 2015 | Sep 25, 2022 | |
| Pat. No. 8338428 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Aug 6, 2023 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8759351 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Aug 6, 2023 | U-1530: Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia |
| Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 19, 2024 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014 | Oct 19, 2024 | |
| Pat. No. 8338427 DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 15, 2025 | U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 8399469 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014 | Jun 29, 2025 | |
| Pat. No. 10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
| Pat. No. 11154553 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2021 | Sep 24, 2033 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
| Pat. No. 10525057 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 31, 2020 | Mar 8, 2034 | U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder U-543: Treatment of schizophrenia |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 25, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder U-543: Treatment of schizophrenia |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 16, 2024 | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 14, 2026 | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 8674825 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 9, 2029 | U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 8956288 DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 6, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| Pat. No. 8945005 DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Aug 19, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 15, 2029 | |
| Pat. No. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 5, 2029 | |
| Pat. No. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| Pat. No. 8847766 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 29, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 27, 2030 | |
| Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 17, 2030 | |
| Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 25, 2030 | |
| Pat. No. 8547248 DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 18, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2031 | |
| Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020 | Jun 13, 2032 | |
| Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Oct 15, 2033 | U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver |
BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-HIV Combinations == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 210251 Prod. No.: 002 RX (EQ 30MG BASE;120MG;EQ 15MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 28, 2021 | Feb 2, 2022 | U-257: Treatment of HIV infection |
| Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 002: Oct 28, 2021 | Apr 17, 2025 | |
| Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 002: Oct 28, 2021 | Aug 15, 2032 | U-257: Treatment of HIV infection |
| Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 28, 2021 | Aug 15, 2032 | U-257: Treatment of HIV infection |
| Pat. No. 9216996 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin- es and methods for treating viral infections Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Oct 28, 2021 | Dec 19, 2033 | |
| Pat. No. 9732092 DS* DP* Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Oct 28, 2021 | Dec 19, 2033 | |
| Pat. No. 9708342 DS* DP* Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 002: Oct 28, 2021 | Jun 19, 2035 | |
| Pat. No. 10385067 Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxa- zepin-8-olate Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 28, 2021 | Jun 19, 2035 | U-257: Treatment of HIV infection |
VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: Antivirals:Anti-hepatitis B (HBV) Agents == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208464 Prod. No.: 001 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2016 | Feb 2, 2022 | U-999: Treatment of chronic hepatitis B in adult patients |
| Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Nov 28, 2016 | Oct 17, 2025 *PED | |
| Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Nov 28, 2016 | Feb 15, 2033 *PED | U-999: Treatment of chronic hepatitis B in adult patients |
| Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2016 | Feb 15, 2033 *PED | U-999: Treatment of chronic hepatitis B in adult patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 4, 2023 | M-255: Information added to the labeling to describe study GS-US-320-4018 in virologically suppressed adults w/ chronic Hep B infection who switched from tenofovir disoproxil fumarate to tenofovir alafenamide |
| Exclusivity Code: M - Miscellaneous | Aug 22, 2023 | M-266: Information added to the labeling to describe study GS-US-320-4035 in virologically suppressed adults w/ chronic Hep B infection who switched from tenofovir disoproxil fumarate to tenofovir alfaenamide |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: KERYX BIOPHARMS NDA No.: 205874 Prod. No.: 001 RX (EQ 210MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753706 DP* Methods for treating renal failure Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 3, 2022 | U-1577: Control of serum phosphorous levels |
| Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Dec 30, 2016 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2017 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Apr 21, 2026 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9387191 DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 | Jul 21, 2030 | |
| Pat. No. 10300039 Ferric citrate dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 21, 2030 | U-2549: Control of serum phosphorus levels |
SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021936 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7988001 DP* Container provided with a pressure equalization opening Claim Types: Device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 | Feb 4, 2022 *PED | |
| Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 | Feb 26, 2025 *PED | |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 | Nov 26, 2025 *PED | |
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 | Apr 10, 2027 *PED | |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015 | Oct 1, 2027 *PED | |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 | Sep 13, 2028 *PED | |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015 | Apr 16, 2031 *PED |
SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA NDA No.: 021929 Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH); 002 RX (0.16MG/INH;0.0045MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7967011 DP* Inhalation device Claim Types: Device Pat. Sub. Date(s): All strengths: None | Feb 11, 2022 *PED | |
| Pat. No. 7759328 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 8143239 DP* Composition for inhalation Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 26, 2012; 002: None | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 8575137 DP* Composition for inhalation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): All strengths: Dec 4, 2013 | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 10166247 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 7, 2019 | Jul 29, 2023 *PED | U-2001: Use for the treatment of asthma in patients 6 years of age and older U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease |
| Pat. No. 8875699 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2014 | May 10, 2025 *PED | |
| Pat. No. 7587988 DP* Inhaler device counter Claim Types: Device Pat. Sub. Date(s): All strengths: None | Oct 10, 2026 *PED | |
| Pat. No. 8387615 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2013; 002: None | Sep 26, 2027 *PED | |
| Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 9, 2013 | Apr 16, 2029 *PED | |
| Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Jan 29, 2014 | Oct 7, 2029 *PED |
KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SUNOVION PHARMS INC NDA No.: 210875 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 14, 2022 | |
| Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 14, 2022 | |
| Pat. No. 10888499 DP* Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jan 14, 2021 | Feb 14, 2022 | |
| Pat. No. 11077068 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Aug 5, 2021 | Feb 14, 2022 | |
| Pat. No. 8663687 DP* Film compositions for delivery of actives Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 2, 2023 | |
| Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Feb 20, 2024 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 3, 2024 | |
| Pat. No. 10821074 DP* Sublingual and buccal film compositions Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 12, 2020 | Aug 7, 2029 | |
| Pat. No. 9044475 DP* Sublingual apomorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | |
| Pat. No. 9283219 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9326981 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669019 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 9669021 Sublingual apomorphine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10420763 DP* Sublingual apomorphine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Jun 11, 2030 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8414922 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 8846074 DP* Sublingual films Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Dec 16, 2031 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10449146 Methods of treating Parkinson's Disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 4, 2020 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Pat. No. 10959943 Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2021 | Apr 19, 2036 | U-2825: Treatment of 'off' episodes in patients with Parkinson's disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 21, 2023 |
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: INDIVIOR INC NDA No.: 022410 Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 3, 2018 | Feb 14, 2022 | |
| Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 3, 2018 | Feb 14, 2022 | |
| Pat. No. 10285910 DP* Sublingual and buccal film compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 7, 2019 | Oct 11, 2022 | |
| Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None | Feb 13, 2023 | |
| Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 3, 2024 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 9687454 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2017 | Aug 7, 2029 | U-1464: Treatment of opioid dependence/sublingual or buccal application |
| Pat. No. 11135216 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Aug 7, 2029 | U-3111: Treating opioid use disorder |
| Pat. No. 8475832 DP* Sublingual and buccal film compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None | Mar 26, 2030 | U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence |
LEVOXYL (TABLET) (ORAL) LEVOTHYROXINE SODIUM [Has competitive generic]
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Thyroid) == L-thyroxine (T4)
NDA Applicant: KING PHARMS NDA No.: 021301 Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium) NDA No.: 021301 Prod. No.: 012 DISC (0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6555581 Levothyroxine compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 15, 2022 | |
| Pat. No. 7067148 DP* Stabilized pharmaceutical and thyroid hormone compositions and method of preparation Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Feb 15, 2022 | |
| Pat. No. 7101569 Methods of administering levothyroxine pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 2, 2023 | U-759: Method of use of administering levothyroxine |
PREVACID IV (INJECTABLE) (INTRAVENOUS) LANSOPRAZOLE
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: TAKEDA PHARMS NA NDA No.: 021566 Prod. No.: 001 DISC (30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7396841 DP* Injections Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Feb 17, 2022 *PED | U-947: When patients are unable to take the oral formulations, PREVACID IV, for injection is indicated as an alternative for the short-term treatment (up to 7 days) of all grades of erosive esophagitis |
METROGEL (GEL) (TOPICAL) METRONIDAZOLE [GENERIC AB]
Drug Classes: Antibacterials:Antibacterials, Other == nitroimidazole antimicrobial
NDA Applicant: GALDERMA LABS LP NDA No.: 021789 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6881726 DP* Aqueous compositions containing metronidazole Claim Types: Formulation; Drug in a container; Process; Product-by-process; Method of use Pat. Sub. Date(s): 001: None | Feb 21, 2022 | U-743: Once a day topical treatment of the inflammatory lesions of rosacea |
| Pat. No. 7348317 DP* Aqueous compositions containing metronidazole Claim Types: Method of use; Kit; Formulation; Process Pat. Sub. Date(s): 001: None | Feb 21, 2022 | U-743: Once a day topical treatment of the inflammatory lesions of rosacea |
OCALIVA (TABLET) (ORAL) OBETICHOLIC ACID
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == farnesoid X receptor (FXR) agonist
NDA Applicant: INTERCEPT PHARMS INC NDA No.: 207999 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8058267 Steroids as agonists for FXR Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Feb 21, 2022 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 8377916 Steroids as agonists for FXR Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Feb 21, 2022 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 7138390 DS* DP* Steroids as agonists for FXR Claim Types: Compound; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Nov 16, 2022 | |
| Pat. No. RE48286 DS* DP* Steroids as agonists for FXR Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 28, 2020 | Nov 16, 2027 | |
| Pat. No. 9238673 DP* Preparation and uses of obeticholic acid Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 22, 2016 | Jun 17, 2033 | |
| Pat. No. 10174073 DS* Preparation and uses of obeticholic acid Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Jan 15, 2019 | Jun 17, 2033 | |
| Pat. No. 10047117 Preparation and uses of obeticholic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 14, 2018 | Sep 6, 2033 | U-1854: Treatment of primary biliary cholangitis (PBC) |
| Pat. No. 10052337 DP* Compositions of obeticholic acid and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 8, 2018 | Apr 26, 2036 | |
| Pat. No. 10751349 DP* Compositions of obeticholic acid and methods of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 28, 2020 | Apr 26, 2036 | |
| Pat. No. 10758549 Compositions of obeticholic acid and methods of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 10, 2020 | Apr 26, 2036 | U-2945: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 27, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 27, 2023 | ODE-119: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as monotherapy in adults unable to tolerate udca |
GENOSYL (GAS) (INHALATION) NITRIC OXIDE [Has competitive generic]
Drug Classes: vasodilator
NDA Applicant: VERO BIOTECH NDA No.: 202860 Prod. No.: 001 RX (800PPM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6758214 DP* Simple nitric oxide generator for ambulatory and/or bedside inhaled NO treatment Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2020 | Feb 23, 2022 | |
| Pat. No. 8226916 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Method of administration; Process Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 8609028 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 8821801 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Claim Types: Device; Part of a device Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | |
| Pat. No. 9522249 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | |
| Pat. No. 9956373 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 10124142 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 18, 2025 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 10814092 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Oct 17, 2025 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 8057742 Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Jan 18, 2026 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 7618594 DP* Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2020 | Oct 17, 2026 | |
| Pat. No. 7947227 Kit for the conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO) Claim Types: Kit; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2021 | Oct 17, 2026 | U-3037: A method of delivering nitric oxide to a patient |
| Pat. No. 7560076 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2020 | Apr 21, 2027 | |
| Pat. No. 9701538 DP* Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Jan 15, 2021 | Jan 28, 2029 | |
| Pat. No. 8944049 DP* Systems and devices for generating nitric oxide Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2021 | Aug 13, 2029 | |
| Pat. No. 9604028 Systems and devices for generating nitric oxide Claim Types: Method of administration Pat. Sub. Date(s): 001: May 5, 2020 | Aug 13, 2029 | U-2793: A method for delivering nitric oxide to a patient with pulmonary hypertension or hypoxia |
| Pat. No. 10926054 DP* Systems and devices for generating nitric oxide Claim Types: Device Pat. Sub. Date(s): 001: Mar 9, 2021 | Aug 13, 2029 | |
| Pat. No. 11103669 DP* Nitric oxide therapies Claim Types: Device Pat. Sub. Date(s): 001: Sep 23, 2021 | Jun 21, 2030 | |
| Pat. No. 8607785 DP* Systems and devices for generating nitric oxide Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2021 | Jul 14, 2030 | |
| Pat. No. 10737051 DP* Nitrogen dioxide storage device Claim Types: Device Pat. Sub. Date(s): 001: Aug 21, 2020 | Oct 20, 2035 | |
| Pat. No. 10213572 DP* Nitrogen dioxide storage cassette Claim Types: Device Pat. Sub. Date(s): 001: May 5, 2020 | Feb 12, 2036 |
PEPCID AC (TABLET, CHEWABLE) (ORAL) FAMOTIDINE
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 020801 Prod. No.: 002 OTC (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6814978 DP* Process for preparing a soft tablet Claim Types: Formulation; Process Pat. Sub. Date(s): 002: None | Feb 26, 2022 *PED |
PEPCID COMPLETE (TABLET, CHEWABLE) (ORAL) CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE [GENERIC OTC]
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 020958 Prod. No.: 001 OTC (800MG;10MG;165MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6814978 DP* Process for preparing a soft tablet Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Feb 26, 2022 *PED |
PRISTIQ (TABLET, EXTENDED RELEASE) (ORAL) DESVENLAFAXINE SUCCINATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: PF PRISM CV NDA No.: 021992 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6673838 DS* [Extended 18 days (0 years)] Succinate salt of O-desmethyl-venlafaxine Claim Types: Compound; New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015 | Mar 1, 2022 | U-1364: Maintenance treatment of major depressive disorder (MDD) U-860: For the approved uses and conditions of use, including depression |
| Pat. No. 8269040 DS* Derivatives of venlafaxine and methods of preparing and using the same Claim Types: Compound Pat. Sub. Date(s): 001: None; 002: None; 003: Feb 2, 2015 | Jul 5, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 6, 2021 | M-222: Addition of data based on the assessment of safety and efficacy in pediatric patients with major depressive disorder to fulfill postmarketing study requirement 1229-1 |
TEKTURNA HCT (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Drug Classes: Cardiovascular Agents:Cardiovascular Agents, Other == Cardiovascular Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular Agents:Diuretics, Thiazide == thiazide diuretic
NDA Applicant: NODEN PHARMA NDA No.: 022107 Prod. No.: 003 RX (EQ 300MG BASE;12.5MG); 004 RX (EQ 300MG BASE;25MG) NDA No.: 022107 Prod. No.: 001 DISC (EQ 150MG BASE;12.5MG); 002 DISC (EQ 150MG BASE;25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9023893 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 3, 2022 | |
| Pat. No. 8618172 DP* Galenical formulations of organic compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 13, 2028 |
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 DISC (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Mar 3, 2022 *PED | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 29, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
| Exclusivity Code: M - Miscellaneous | Feb 15, 2022 | M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 209210 Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 3, 2017 | Mar 3, 2022 *PED | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8895033 DP* Sustained release formulations using non-aqueous carriers Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 4, 2031 *PED | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 15, 2022 | M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 DISC (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Mar 28, 2014 | Mar 3, 2022 *PED | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 9, 2023 *PED | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 15, 2024 *PED | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Feb 17, 2016 | Oct 15, 2024 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 13, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Dec 30, 2025 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Apr 4, 2026 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 6, 2018 | Feb 18, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 20, 2027 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | May 12, 2028 *PED | |
| Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Jul 12, 2028 *PED | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 21, 2028 *PED | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Sep 25, 2028 *PED | |
| Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Sep 25, 2028 *PED | |
| Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Aug 4, 2029 *PED | |
| Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Nov 19, 2029 *PED | |
| Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 7, 2030 *PED | |
| Pat. No. 8721615 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jul 18, 2030 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
| Exclusivity Code: M - Miscellaneous | Feb 15, 2022 | M-240: Information added to labeling regarding a randomized, placebo-controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with Type 2 diabetes mellites |
| Exclusivity Code: NPP - New patient population | Jan 22, 2025 PED |
PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Contraceptives:Contraceptives, Other
NDA Applicant: EVOFEM INC NDA No.: 208352 Prod. No.: 001 RX (1%;1.8%;0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6706276 DP* Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 6, 2022 | |
| Pat. No. 10568855 Compositions and methods for enhancing the efficacy of contraceptive microbicides Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 3, 2020 | Mar 15, 2033 | U-1: Prevention of pregnancy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 22, 2023 |
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: Antineoplastics:Treatment Adjuncts == Antineoplastics:Antineoplastics, Other == folate analog
NDA Applicant: ACROTECH NDA No.: 020140 Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140 Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)] Substantially pure diastereoisomers of tetrahydrofolate derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011 | Mar 7, 2022 |
VIMPAT (TABLET) (ORAL) LACOSAMIDE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022253 Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Mar 17, 2022 | U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older U-2140: Method of treating partial onset seizures in patients 4 years of age and older U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 16, 2023 | I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older |
VIMPAT (SOLUTION) (INTRAVENOUS) LACOSAMIDE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022254 Prod. No.: 001 RX (200MG/20ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Mar 17, 2022 | U-1565: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older when oral administration is temporarily not feasible U-1568: Method of treating, as monotherapy or adjunctive therapy, partial-onset seizures in a patient with epilepsy aged 17 years and older when oral administration is temporarily not feasible U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 16, 2023 | I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older |
| Exclusivity Code: NPP - New patient population | Nov 16, 2023 |
VIMPAT (SOLUTION) (ORAL) LACOSAMIDE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: UCB INC NDA No.: 022255 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE38551 DS* DP* [Extended 5 years] Anticonvulsant enantiomeric amino acid derivatives Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Mar 17, 2022 | U-1567: Method of treating, as initial loading dose for monotherapy or adjunctive therapy, partial onset-seizures in a patient with epilepsy aged 17 years or older U-2140: Method of treating partial onset seizures in patients 4 years of age and older U-2989: Method of use as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older U-2990: Method of use for treatment of partial-onset seizures in patients 4 years of age and older U-2999: Method of use of treating, as an initial loading dose for monotherapy or adjunctive therapy in partial onset seizure patients with epilepsy aged 17 years or older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 16, 2023 | I-878: Addition of a new indication for adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older |
SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021395 Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6777423 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. 6908928 DS* DP* Crystalline tiotropium bromide monohydrate, processes for the preparation thereof,and pharmaceutical compositions Claim Types: Composition; Product-by-process; Method of use Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema U-762: Treatment of chronic obstructive pulmonary disease |
| Pat. No. 7309707 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. 7642268 DS* DP* Crystalline micronisate, process for the manufacture thereof and use thereof for the preparation of a medicament Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: None | Mar 24, 2022 *PED | |
| Pat. No. RE38912 DP* Process for preparing powder formulations Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Apr 11, 2022 *PED | |
| Pat. No. 7070800 DP* Inhalable powder containing tiotropium Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 22, 2022 *PED | U-566: For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
| Pat. No. 8022082 DP* Method for the administration of an anticholinergic by inhalation Claim Types: Method of administration; Kit Pat. Sub. Date(s): 001: Oct 24, 2011 | Jul 19, 2026 *PED | U-1186: Administration of an inhalable powder comprising tiotropium via device |
| Pat. No. 7694676 DP* Dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jun 13, 2011 | Sep 12, 2027 *PED | |
| Pat. No. 9010323 DP* Inhaler and sieve for an inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 20, 2017 | Apr 19, 2030 |
TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: SALIX NDA No.: 208745 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8637451 Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 14, 2017 | Mar 28, 2022 | U-1964: Elevation of intracellular cGMP resulting in increased intestinal fluid and accelerated transit |
| Pat. No. 7799897 DS* Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Feb 14, 2017 | Jun 9, 2022 | |
| Pat. No. 7041786 DS* Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: Feb 14, 2017 | Jan 30, 2028 | |
| Pat. No. 9610321 Formulations of guanylate cyclase C agonists and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: May 1, 2017 | Sep 15, 2031 | U-1999: Chronic idiopathic constipation U-2230: Irritable bowel syndrome with constipation |
| Pat. No. 9919024 Formulations of guanylate cyclase C agonists and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 10, 2018 | Sep 15, 2031 | U-1999: Chronic idiopathic constipation U-2230: Irritable bowel syndrome with constipation |
| Pat. No. 9925231 DP* Formulations of guanylate cyclase C agonists and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2018 | Sep 15, 2031 | |
| Pat. No. 9616097 DP* Formulations of guanylate cyclase C agonists and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: May 1, 2017 | Aug 20, 2032 | |
| Pat. No. 10011637 DS* Ultra-pure agonists of guanylate cyclase C, method of making and using same Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 19, 2018 | Jun 5, 2034 | |
| Pat. No. 11142549 DP* Ultra-pure agonists of guanylate cyclase C, method of making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 25, 2021 | Jun 5, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 24, 2021 | I-764: Treatment in adult patients for irritable bowel syndrome with constipation (IBS-C) |
| Exclusivity Code: NCE - New chemical entity | Jan 19, 2022 |
ARESTIN (POWDER, EXTENDED RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents == tetracycline-class drug
NDA Applicant: ORAPHARMA NDA No.: 050781 Prod. No.: 001 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6682348 DP* Dispensing apparatus and cartridge Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 24, 2012 | Mar 29, 2022 | |
| Pat. No. 7699609 DP* Dispensing apparatus and cartridge with deformable tip Claim Types: Device Pat. Sub. Date(s): 001: Mar 26, 2015 | Mar 29, 2022 |
NOXAFIL (SUSPENSION) (ORAL) POSACONAZOLE
Drug Classes: Antifungals == azole antifungal
NDA Applicant: SCHERING NDA No.: 022003 Prod. No.: 001 RX (40MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263600 DP* Antifungal composition with enhanced bioavailability Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 1, 2022 |
ORACEA (CAPSULE) (ORAL) DOXYCYCLINE
Drug Classes: Antibacterials:Tetracyclines == Dental and Oral Agents == tetracycline-class drug
NDA Applicant: GALDERMA LABS LP NDA No.: 050805 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7211267 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 7232572 Methods of treating rosacea Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8603506 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 9241946 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2016 | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 10058564 Methods of treating acne Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2018 | Apr 5, 2022 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8394405 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8394406 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 25, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8470364 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 26, 2013 | Apr 7, 2024 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8709478 Once daily formulations of tetracyclines Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2014 | Apr 7, 2024 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 8206740 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 24, 2025 | U-925: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
| Pat. No. 7749532 DP* Once daily formulations of tetracyclines Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Dec 19, 2027 | U-1063: Treatment of only inflammatory lesions (papules and pustules) of rosacea |
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS NDA No.: 022161 Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6403567 DS* DP* [Extended 1024 days (2.8 years)] N-pyrazole A2A adenosine receptor agonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: None | Apr 10, 2022 | U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart |
| Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 2, 2019 | Feb 2, 2027 | |
| Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2012 | Feb 2, 2027 |
CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CIPHER PHARMS INC NDA No.: 022370 Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858118 DP* Extended release composition containing Tramadol Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 11, 2022 | U-1104: Use of tramadol for the management of moderate to moderately severe chronic pain |
WELCHOL (BAR, CHEWABLE) (ORAL) COLESEVELAM HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Cardiovascular Agents:Dyslipidemics, Other == bile acid sequestrant
NDA Applicant: DAIICHI SANKYO INC NDA No.: 210895 Prod. No.: 001 DISC (3.75GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2019 | Apr 17, 2022 | U-2516: A method for reducing serum glucose levels in adults with Type 2 diabetes mellitus |
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021398 Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012 | Apr 19, 2022 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013 | Apr 19, 2022 | U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma |
| Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017 | Apr 19, 2022 | U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid |
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: THE MEDICINES CO NDA No.: 021338 Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6881208 Method and device for transdermal electrotransport delivery of fentanyl and sufentanil Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: None | Apr 1, 2024 | |
| Pat. No. 8301238 DP* Two-part electrotransport device Claim Types: Device Pat. Sub. Date(s): 001: None | Sep 30, 2031 | |
| Pat. No. 9364656 Method of storing an electrotransport drug delivery device Claim Types: Process Pat. Sub. Date(s): 001: Jun 21, 2016 | Sep 30, 2031 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9731121 DP* Switch validation circuit and method Claim Types: Device Pat. Sub. Date(s): 001: Sep 12, 2017 | Oct 17, 2031 | |
| Pat. No. 8781571 DP* Switch validation circuit and method Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 001: May 28, 2015 | Mar 31, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8428708 Self-test for analgesic product Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: None | May 21, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 8428709 DP* Current control for electrotransport drug delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: May 28, 2015 | Jun 11, 2032 | U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride |
| Pat. No. 9095706 DP* Self-test for analgesic product Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 3, 2033 |
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Apr 26, 2022 | U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor |
| Pat. No. 7166722 DS* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 6, 2021 | Nov 16, 2023 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 10, 2026 |
CERDELGA (CAPSULE) (ORAL) ELIGLUSTAT TARTRATE [GENERIC AB]
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == glucosylceramide synthase inhibitor
NDA Applicant: GENZYME CORP NDA No.: 205494 Prod. No.: 001 RX (EQ 84MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916802 DS* Amino ceramide-like compounds and therapeutic methods of use Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Sep 15, 2014 | Apr 29, 2022 | U-1571: Treatment of Gaucher disease type 1 |
| Pat. No. 7253185 DP* Amino ceramide-like compounds and therapeutic methods of use Claim Types: Composition Pat. Sub. Date(s): 001: May 10, 2018 | Apr 29, 2022 | |
| Pat. No. 7615573 Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2014 | Apr 29, 2022 | U-1571: Treatment of Gaucher disease type 1 |
| Pat. No. 7196205 DS* [Extended 1519 days (4.2 years)] Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Oct 21, 2014 | Jun 26, 2026 | |
| Pat. No. 10888547 Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2021 | Jan 31, 2031 | U-3042: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 poor metabolizers with 84 mg once daily of eliglustat (equivalent to 100 mg of eliglustat tartrate) U-3043: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive or intermediate metabolizers with 84 mg twice per day of eliglustat (equivalent to 100 mg of eliglustat tartrate twice per day) |
| Pat. No. 10888544 Methods for treating Gaucher disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2021 | Dec 13, 2038 | U-3040: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with mild hepatic impairment and are concurrently taking a strong or moderate cyp3a inhibitor U-3041: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with moderate to severe renal impairment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 19, 2021 | ODE-73: Long-term treatment of adult patients with gaucher disease type 1 who are cyp2d6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. |
LYNPARZA (CAPSULE) (ORAL) OLAPARIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 206162 Prod. No.: 001 DISC (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7151102 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 29, 2022 | |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Mar 12, 2024 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Oct 11, 2024 | |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 12, 2027 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Pat. No. 8247416 DS* Phthalazinone derivative Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 24, 2028 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 4, 2031 | U-1634: Treatment of BRCA mutated ovarian cancer using PARP inhibitor |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2021 | ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 208558 Prod. No.: 001 RX (100MG); 002 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7151102 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Apr 29, 2022 | |
| Pat. No. 8912187 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Mar 12, 2024 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability |
| Pat. No. 9169235 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Mar 12, 2024 | U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone |
| Pat. No. 9566276 Phthalazinone derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 22, 2020 | Mar 12, 2024 | U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Pat. No. 7449464 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 7981889 DS* DP* Phthalazinone derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Oct 11, 2024 | |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 18, 2020 | Aug 12, 2027 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 12, 2027 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone |
| Pat. No. 8475842 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-p- hthalazin-1-one Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Dec 31, 2029 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 15, 2017 | Aug 4, 2031 | U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2103: Maintenance treatment of BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy U-2481: Treatment of deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 12, 2021 | I-762: Treatment of deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting |
| Exclusivity Code: I - New Indication | Dec 19, 2021 | I-776: Firstline maintenance tx in pts w/ deleterious or suspected deleterious germline, somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal CA who are in complete or partial response to firstline platinum-based chemotherapy |
| Exclusivity Code: I - New Indication | Dec 27, 2022 | I-818: Maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen |
| Exclusivity Code: I - New Indication | May 8, 2023 | I-831: W/bevacizumab for maintenance tx of adults w/adv. epithelial ovarian, fallopian tube or primary peritoneal ca in complete or partial response to first-line platinum-based chemo & ca associated w/ homologous recombination deficiency positive status |
| Exclusivity Code: I - New Indication | May 19, 2023 | I-832: Tx of adult pts with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 17, 2024 | ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2025 | ODE-226: Maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 27, 2026 | ODE-283: Maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose dz has not progressed on >=16wks of 1st line platinum based chemo regimen. select pts for therapy based on approved companion diagnostic |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 8, 2027 | ODE-306: W/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal CA in complete or partial response to 1st line pt based chemo & whose CA is assoc w/ homologous recomb def + status defined by genomic instability |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2021 | ODE-83: Use of as monotherapy for patients with deleterious or suspected deleterious germline brca mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy |
NEXTERONE (INJECTABLE) (INJECTION) AMIODARONE HYDROCHLORIDE
Drug Classes: Cardiovascular Agents:Antiarrhythmics
NDA Applicant: BAXTER HLTHCARE NDA No.: 022325 Prod. No.: 002 RX (150MG/100ML (1.5MG/ML)); 003 RX (360MG/200ML (1.8MG/ML)) NDA No.: 022325 Prod. No.: 001 DISC (50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6869939 DP* Formulations containing amiodarone and sulfoalkyl ether cyclodextrin Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | May 4, 2022 | |
| Pat. No. 7635773 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 13, 2029 |
EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: GW RES LTD NDA No.: 210365 Prod. No.: 001 RX (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10195159 DS* Processes and apparatus for extraction of active substances and enriched extracts from natural products Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2019 | May 7, 2022 | |
| Pat. No. 11154516 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 4, 2021 | Jun 17, 2034 | U-3235: Use for the treatment of seizures associated with dravet syndrome U-3236: Use for the treatment of seizures associated with Lennox-Gastaut syndrome |
| Pat. No. 9949937 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2421: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome |
| Pat. No. 9956183 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2422: Use in combination with clobazam for the treatment of seizures in patients with lennox gastaut syndrome who have been previously treated with clobazam U-2423: Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome who have been previously treated with clobazam |
| Pat. No. 9956184 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2424: Use in combination with clobazam for treatment of seizures in patients with lennox gastaut syndrome |
| Pat. No. 9956185 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2425: Use for the treatment of convulsive seizures in patients with Dravet Syndrome |
| Pat. No. 9956186 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2426: Use for the treatment of convulsive seizures in patients with Lennox Gastaut Syndrome |
| Pat. No. 10092525 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jun 17, 2035 | U-2427: Use for the treatment of drop seizures in patients with Dravet Syndrome |
| Pat. No. 10111840 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 27, 2018 | Jun 17, 2035 | U-2442: Use for the treatment of atonic seizures in patients with Lennox-Gastaut syndrome U-2443: Use for the treatment of atonic seizures in patients with Dravet syndrome |
| Pat. No. 10137095 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2018 | Jun 17, 2035 | U-2454: Use for the treatment of drop seizures in patients with Lennox-Gastaut Syndrome U-2455: Use in combination with clobazam for treatment of drop seizures in patients with Lennox Gastaut Syndrome |
| Pat. No. 10603288 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 27, 2020 | Jun 17, 2035 | U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome U-2781: Use for the treatment of seizures in patients with Dravet syndrome U-2782: Use for reducing convulsive seizure frequency in patients with Lennox Gastaut syndrome U-2783: Use for reducing convulsive seizure frequency in patients with Dravet syndrome |
| Pat. No. 10709671 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 30, 2020 | Jun 17, 2035 | U-2862: Use for the treatment of focal seizures in patients with Dravet syndrome |
| Pat. No. 10709673 DP* Use of cannabinoids in the treatment of epilepsy Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 30, 2020 | Jun 17, 2035 | |
| Pat. No. 10709674 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 30, 2020 | Jun 17, 2035 | U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome U-2781: Use for the treatment of seizures in patients with Dravet syndrome |
| Pat. No. 10849860 Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 18, 2020 | Jun 17, 2035 | U-2427: Use for the treatment of drop seizures in patients with Dravet Syndrome U-2454: Use for the treatment of drop seizures in patients with Lennox-Gastaut Syndrome |
| Pat. No. 10966939 DP* Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Apr 30, 2021 | Jun 17, 2035 | U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome U-2781: Use for the treatment of seizures in patients with Dravet syndrome |
| Pat. No. 10918608 Use of cannabidiol in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 26, 2021 | Oct 14, 2035 | U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex U-3072: Use for the treatment of generalized seizures or focal seizures with impairment in patients with tuberous sclerosis complex U-3073: Use for reducing seizure frequency in patients with tuberous sclerosis complex |
| Pat. No. 11065209 Use of cannabidiol in the treatment of epilepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2021 | Oct 14, 2035 | U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex |
| Pat. No. 11096905 DS* DP* Use of cannabinoids in the treatment of epilepsy Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Sep 16, 2021 | Oct 14, 2035 | U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome U-2781: Use for the treatment of seizures in patients with Dravet syndrome |
| Pat. No. 11160795 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 4, 2021 | Mar 1, 2041 | U-3233: Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2023 | |
| Exclusivity Code: NPP - New patient population | Jul 31, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2025 | ODE-216: Indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) in patients 2 years of age and older |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 31, 2027 | ODE-326: Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients between 1 and 2 years of age |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 31, 2027 | ODE-332: Treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 year of age and older |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 6, 2016 | May 10, 2022 | U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product |
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 1, 2017 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 6, 2018 | Apr 4, 2023 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Mar 30, 2025 |
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 205777 Prod. No.: 003 DISC (20MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969369 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 3, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9056051 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jun 30, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9084729 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Jul 22, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9161937 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9168252 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 27, 2015 | May 10, 2022 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9283216 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9283221 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Mar 15, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9345701 DP* Abuse-resistant controlled-release opioid dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: May 24, 2016 | May 10, 2022 | U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate |
| Pat. No. 9511066 Abuse-resistant controlled-release opioid dosage form Claim Types: Method of use Pat. Sub. Date(s): 003: Dec 6, 2016 | May 10, 2022 | U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product |
| Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 30, 2014 | Apr 4, 2023 | |
| Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone Claim Types: Formulation; Process Pat. Sub. Date(s): 003: Aug 3, 2015 | Mar 30, 2025 | |
| Pat. No. 9522919 DS* DP* Oxycodone compositions Claim Types: Formulation Pat. Sub. Date(s): 003: Dec 20, 2016 | Mar 30, 2025 |
PROTONIX IV (INJECTABLE) (INTRAVENOUS) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors
NDA Applicant: WYETH PHARMS NDA No.: 020988 Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6780881 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | May 17, 2022 *PED | |
| Pat. No. 7351723 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Composition Pat. Sub. Date(s): 001: None | May 17, 2022 *PED | |
| Pat. No. 8754108 DP* Freeze-dried pantoprazole preparation and pantoprazole injection Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 17, 2022 *PED |
PEMFEXY (SOLUTION) (INTRAVENOUS) PEMETREXED
Drug Classes: Antineoplastics:Antineoplastics, Other == folate analog metabolic inhibitor
NDA Applicant: EAGLE PHARMS NDA No.: 209472 Prod. No.: 001 RX (500MG/20ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7772209 Antifolate combination therapies Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 10, 2020 | May 24, 2022 | U-2728: Use of pemetrexed with prior and/or repeated vitamin B12 and folic acid administration in patients with non-squamous non-small cell lung cancer U-2729: Use of pemetrexed with prior and/or repeated vitamin B12 and folic acid administration in patients with mesothelioma |
| Pat. No. 9604990 DS* Crystalline forms of pemetrexed diacid and manufacturing processes therefor Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: Jul 28, 2020 | Oct 28, 2035 |
ALIMTA (POWDER) (INTRAVENOUS) PEMETREXED DISODIUM
Drug Classes: Antineoplastics:Antineoplastics, Other == folate analog metabolic inhibitor
NDA Applicant: LILLY NDA No.: 021462 Prod. No.: 001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7772209 Antifolate combination therapies Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | May 24, 2022 *PED | U-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration |
RYTARY (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == Antiparkinson Agents:Antiparkinson Agents, Other == aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX LABS INC NDA No.: 203312 Prod. No.: 001 RX (23.75MG;95MG); 002 RX (36.25MG;145MG); 003 RX (48.75MG;195MG); 004 RX (61.25MG;245MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094427 DP* DLR* Combination immediate release controlled release levodopa/carbidopa dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | May 29, 2022 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication |
| Pat. No. 8377474 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-219: Treatment of Parkinson's disease |
| Pat. No. 8454998 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1646: Treatment of post-encephalitic Parkinsonism, and Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1647: Treatment of Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1649: Treatment of post-encephalitic Parkinsonism U-219: Treatment of Parkinson's disease |
| Pat. No. 8557283 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-219: Treatment of Parkinson's disease |
| Pat. No. 9089607 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 10, 2015 | Dec 26, 2028 | U-1645: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication U-1720: Method of providing a therapeutically effective and stable median blood plasma level of levodopa |
| Pat. No. 9089608 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 10, 2015 | Dec 26, 2028 | |
| Pat. No. 9463246 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 12, 2016 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
| Pat. No. 9533046 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 11, 2017 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
| Pat. No. 9901640 DP* Controlled release formulations of levodopa and uses thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 28, 2018 | Dec 26, 2028 | U-219: Treatment of Parkinson's disease |
ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021394 Prod. No.: 001 OTC (38MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8263647 DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 30, 2022 |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 001 RX (EQ 20MG BASE;500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2013 | May 31, 2022 | |
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2017 | May 31, 2022 | |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 28, 2016 | Mar 10, 2031 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON NDA No.: 022511 Prod. No.: 002 RX (EQ 20MG BASE;375MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 29, 2013 | May 31, 2022 | |
| Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 29, 2014 | May 31, 2022 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2015 | May 31, 2022 | U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment |
| Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 17, 2015 | May 31, 2022 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 23, 2016 | May 31, 2022 | |
| Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 17, 2017 | May 31, 2022 | |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Feb 28, 2023 | U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer |
| Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 002: Aug 17, 2016 | Sep 3, 2029 | U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment |
| Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Mar 2, 2015 | Oct 17, 2031 | U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin |
YOSPRALA (TABLET, DELAYED RELEASE) (ORAL) ASPIRIN; OMEPRAZOLE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents == anti-platelet agent == nonsteroidal anti-inflammatory drug == Gastrointestinal Agents:Proton Pump Inhibitors == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: GENUS LIFESCIENCES NDA No.: 205103 Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9364439 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | May 31, 2022 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 8206741 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2016 | Feb 28, 2023 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
| Pat. No. 9987231 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 3, 2018 | Jan 2, 2033 | U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers |
| Pat. No. 9539214 Compositions and methods for delivery of omeprazole plus acetylsalicylic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 27, 2017 | Mar 13, 2033 | U-1902: Treatment or secondary prevention of cardiovascular disease, cardiovascular events, or cerebrovascular events and risk-reduction of aspirin-associated gastric ulcers |
MYTESI (TABLET, DELAYED RELEASE) (ORAL) CROFELEMER
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == antidiarrheal
NDA Applicant: NAPO PHARMS INC NDA No.: 202292 Prod. No.: 001 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7341744 DP* [Extended 1075 days (2.9 years)] Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 2, 2022 | U-1319: Symptomatic relief of non-infectious diarrhea |
| Pat. No. 8962680 Methods and compositions for treating HIV-associated diarrhea Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 24, 2015 | Oct 31, 2031 | U-1319: Symptomatic relief of non-infectious diarrhea |
| Pat. No. 9585868 Methods and compositions for treating HIV-associated diarrhea Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 24, 2017 | Oct 31, 2031 | U-1319: Symptomatic relief of non-infectious diarrhea |
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018 | Jun 8, 2022 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2020 | Apr 21, 2035 | |
| Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 11, 2020 | Apr 21, 2035 | |
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
FYCOMPA (TABLET) (ORAL) PERAMPANEL
Drug Classes: Anticonvulsants:Anticonvulsants, Other == non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC NDA No.: 202834 Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 19, 2012 | Jun 8, 2022 | U-106: Treatment of epilepsy U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older |
| Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 6, 2014 | Jul 1, 2026 |
FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: Anticonvulsants:Anticonvulsants, Other == non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC NDA No.: 208277 Prod. No.: 001 RX (0.5MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 27, 2016 | Jun 8, 2022 | U-106: Treatment of epilepsy U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older |
| Pat. No. 8772497 DS* Method for producing 1, 2-dihydropyridine-2-one compound Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: May 27, 2016 | Jul 1, 2026 |
ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC NDA No.: 021150 Prod. No.: 002 OTC (5MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jun 10, 2022 | |
| Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jun 10, 2022 | U-295: Treatment of seasonal and perennial allergic rhinitis symptoms |
RYANODEX (FOR SUSPENSION) (INTRAVENOUS) DANTROLENE SODIUM
Drug Classes: Antispasticity Agents == skeletal muscle relaxant
NDA Applicant: EAGLE PHARMS NDA No.: 205579 Prod. No.: 001 RX (250MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9884044 DP* Treatment using dantrolene Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2018 | Jun 13, 2022 | U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk. |
| Pat. No. 8110225 DP* Treatment using dantrolene Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 28, 2014 | Dec 24, 2022 | |
| Pat. No. 8604072 DP* Treatment using dantrolene Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 28, 2014 | Dec 24, 2022 | |
| Pat. No. 8685460 Treatment using dantrolene Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 8, 2014 | Feb 15, 2023 | U-1546: For use in the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk. |
| Pat. No. 7758890 DP* Treatment using dantrolene Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2014 | Jul 1, 2025 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 22, 2021 | ODE-69: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk |
BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN [GENERIC AN]
Drug Classes: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: CHIESI NDA No.: 201820 Prod. No.: 001 RX (300MG/4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2013 | Jun 14, 2022 | U-1324: Management of cystic fibrosis patients |
| Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 | |
| Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 30, 2013 | Sep 22, 2022 |
GLEEVEC (CAPSULE) (ORAL) IMATINIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 021335 Prod. No.: 001 DISC (EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 002 DISC (EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6958335 Treatment of gastrointestinal stromal tumors Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2022 *PED | U-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) |
GLEEVEC (TABLET) (ORAL) IMATINIB MESYLATE [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 021588 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6958335 Treatment of gastrointestinal stromal tumors Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2022 *PED | U-1883: Treatment of gastrointestinal stromal tumors (GIST) U-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) |
GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN NDA No.: 202513 Prod. No.: 001 DISC (3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 27, 2012 | Jun 25, 2022 |
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ONCOPEPTIDES AB NDA No.: 214383 Prod. No.: 001 DISC (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6992207 DS* DP* Melphalan derivatives and their use as cancer chemotherapeutic drugs Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Jun 25, 2022 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy |
| Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021 | Apr 25, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2028 | ODE-348: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody |
JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor == Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 202343 Prod. No.: 001 DISC (10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 002 DISC (20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 003 DISC (40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 004 DISC (10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 005 DISC (20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 006 DISC (40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168637 DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 23, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 26, 2022 | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
| Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Jan 26, 2023 *PED | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
| Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Jan 26, 2023 *PED | U-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin U-1190: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with insulin U-1192: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a sulfonylurea (such as glipizide, glimepiride and glyburide) U-1193: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a PPAR-gamma agonist (such as pioglitazone and rosiglitazone) |
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Oct 11, 2026 *PED | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8815801 DP* Controlled release composition and method of producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015 | Jun 28, 2022 | |
| Pat. No. 8921326 DP* Sustained-release composition and method for producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015 | Feb 5, 2031 | U-1666: Palliative treatment of prostate cancer |
STIVARGA (TABLET) (ORAL) REGORAFENIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 203085 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7351834 DS* [Extended 898 days (2.5 years)] .omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Oct 23, 2012 | Jun 28, 2022 | |
| Pat. No. 8680124 Treatment of cancers with acquired resistance to kit inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2014 | Jun 2, 2030 | U-1506: Treatment of patients with gastrointestinal stromal tumor (GIST), including but not limited to patients previously treated with imatinib and patients with GIST having resistance to a KIT tyrosine kinase inhibitor |
| Pat. No. 8637553 DS* DP* Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 21, 2014 | Feb 16, 2031 | |
| Pat. No. 9458107 DP* Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-- ethylpyridie-carboxamide, its salts and monohydrate Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 2, 2016 | Apr 8, 2031 | |
| Pat. No. 9957232 DS* 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate Claim Types: Compound; Composition; Method of use; Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 30, 2018 | Jul 9, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 27, 2024 | ODE-139: Treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. |
PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE [GENERIC AB]
Drug Classes: Blood Products and Modifiers:Anticoagulants
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 022512 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 110MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6087380 DS* DP* [Extended 1409 days (3.9 years)] Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Dec 15, 2015 | Jun 28, 2022 *PED | U-1931: Prophylaxis or treatment of venous and arterial thrombotic disease |
| Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2018 | Dec 14, 2023 *PED | |
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 1, 2011; 002: None; 003: Dec 15, 2015 | Mar 7, 2026 *PED | |
| Pat. No. 7866474 DP* DLR* Film container Claim Types: Device Pat. Sub. Date(s): 001: Aug 1, 2011; 002: Aug 1, 2011; 003: Dec 15, 2015 | Mar 2, 2028 *PED | |
| Pat. No. 9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 9, 2015; 002: Nov 9, 2015; 003: Dec 15, 2015 | Jul 20, 2031 *PED | U-1759: Method of reversing the anticoagulant effect of dabigatran using idarucizumab |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 21, 2024 PED | I-862: Treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated |
PRADAXA (PELLETS) (ORAL) DABIGATRAN ETEXILATE MESYLATE
Drug Classes: Blood Products and Modifiers:Anticoagulants
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 214358 Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 30MG BASE/PACKET); 003 RX (EQ 40MG BASE/PACKET); 004 RX (EQ 50MG BASE/PACKET); 005 RX (EQ 110MG BASE/PACKET); 006 RX (EQ 150MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6087380 DS* DP* [Extended 1409 days (3.9 years)] Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions Claim Types: Compound; Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Jun 28, 2022 *PED | U-3177: Treatment of venous thrombotic disease U-3178: Reduce the risk of recurrence of venous thrombotic disease |
| Pat. No. 9925174 DP* Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol acid ethyl ester and the salts thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Dec 14, 2023 *PED | |
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Mar 7, 2026 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 21, 2024 PED |
LUSEDRA (SOLUTION) (INTRAVENOUS) FOSPROPOFOL DISODIUM
NDA Applicant: EISAI INC NDA No.: 022244 Prod. No.: 001 DISC (1050MG/30ML (35MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6204257 DS* DP* [Extended 1424 days (3.9 years)] Water soluble prodrugs of hindered alcohols Claim Types: Compound; Composition; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 1, 2022 | U-945: Sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation |
SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: Anti-Obesity Agents == Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 206321 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899699 DP* Automatic injection device with reset feature Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jan 21, 2015 | Jul 1, 2022 *PED | |
| Pat. No. 8672898 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Jul 2, 2022 *PED | |
| Pat. No. 9486588 DP* Automatic injection device with reset feature Claim Types: Device Pat. Sub. Date(s): 001: Dec 7, 2016 | Jul 2, 2022 *PED | |
| Pat. No. 8846618 DP* Stable formulation of modified GLP-1 Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Dec 27, 2022 *PED | |
| Pat. No. 6268343 DS* DP* [Extended 5 years] Derivatives of GLP-1 analogs Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 22, 2023 *PED | U-1255: Method for chronic weight management by treating obesity |
| Pat. No. 8579869 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Dec 30, 2023 *PED | |
| Pat. No. 7762994 DP* Needle mounting system and a method for mounting a needle assembly Claim Types: Device Pat. Sub. Date(s): 001: Jan 23, 2019 | Nov 23, 2024 *PED | |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 8, 2019 | Jan 20, 2026 | |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 20, 2026 | |
| Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 21, 2015 | Feb 13, 2026 *PED | |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2015 | Apr 20, 2026 *PED | |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 22, 2021 | Jul 17, 2026 | |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2018 | Jul 20, 2026 *PED | |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Jul 26, 2026 *PED | |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 | Jan 17, 2027 *PED | |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Claim Types: Device Pat. Sub. Date(s): 001: Nov 13, 2017 | Jan 17, 2027 *PED | |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Claim Types: Device Pat. Sub. Date(s): 001: Apr 1, 2019 | Jan 17, 2027 *PED | |
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 10, 2017 | Feb 3, 2027 *PED | |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2017 | Aug 27, 2027 *PED | |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Claim Types: Device Pat. Sub. Date(s): 001: Oct 26, 2016 | Mar 27, 2028 *PED | |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Claim Types: Device Pat. Sub. Date(s): 001: Sep 18, 2015 | Aug 1, 2032 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2018 | Jul 9, 2037 *PED | U-2438: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with Type 2 diabetes and cardiovascular disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 4, 2023 |
ULESFIA (LOTION) (TOPICAL) BENZYL ALCOHOL
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: SHIONOGI INC NDA No.: 022129 Prod. No.: 001 DISC (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6793931 DP* Ectoparasite asphyxiator compositions and methods for their applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jul 11, 2022 | U-970: Topical treatment of lice infestations |
| Pat. No. 7294342 Ectoparasite asphyxiator compositions and methods for their application Claim Types: Method of use Pat. Sub. Date(s): 001: None | May 19, 2024 | U-970: Topical treatment of lice infestations |
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6028071 DS* DP* [Extended 5 years] Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Jul 16, 2022 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 31, 2025 | U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None | May 31, 2025 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
AXID (SOLUTION) (ORAL) NIZATIDINE
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist
NDA Applicant: BRAINTREE NDA No.: 021494 Prod. No.: 001 DISC (15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6930119 DP* Liquid pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 17, 2022 |
VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
Drug Classes: sclerosing agent
NDA Applicant: PROVENSIS NDA No.: 205098 Prod. No.: 001 RX (180MG/18ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6846412 DP* Combination filter assembly Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Jul 19, 2022 | |
| Pat. No. 8122917 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit Pat. Sub. Date(s): 001: None | Sep 9, 2024 | |
| Pat. No. 7731986 DS* DP* Therapeutic foam Claim Types: Formulation; Drug in a container; Device; Process; Method of use Pat. Sub. Date(s): 001: None | Nov 17, 2024 | U-1463: A method of intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities |
| Pat. No. 7814943 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit; Method of use Pat. Sub. Date(s): 001: None | Nov 19, 2027 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 9480652 DP* Aerosol valve Claim Types: Device; Process Pat. Sub. Date(s): 001: Nov 30, 2016 | May 12, 2032 |
WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: SUN PHARM NDA No.: 213433 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8865690 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2020 | Jul 24, 2022 | U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate |
| Pat. No. 9211295 DP* 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Sep 4, 2020 | Jul 24, 2022 | |
| Pat. No. 8143240 17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2020 | Jan 12, 2023 | U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate |
| Pat. No. 9486458 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2020 | Jul 24, 2028 | U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate |
| Pat. No. 10159682 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2020 | Aug 14, 2028 | U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate |
| Pat. No. 9433628 DP* Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition Pat. Sub. Date(s): 001: Sep 4, 2020 | Feb 8, 2029 | |
| Pat. No. 8785427 DP* Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: Sep 4, 2020 | Jul 25, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 26, 2025 |
VELCADE (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) BORTEZOMIB
Drug Classes: proteasome inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 021602 Prod. No.: 001 RX (3.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6713446 DS* DP* Formulation of boronic acid compounds Claim Types: Compound; Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Pat. No. 6958319 DS* DP* Formulation of boronic acid compounds Claim Types: Compound; Process; Composition Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 8, 2022 PED | ODE-76: Treatment of patients with mantle cell lymphoma who have not received at least 1 prior therapy |
ZETIA (TABLET) (ORAL) EZETIMIBE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor
NDA Applicant: ORGANON NDA No.: 021445 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030106 DP* Sterol absorption inhibitor compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 25, 2022 *PED | |
| Pat. No. 7612058 Methods for inhibiting sterol absorption Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 30, 2026 *PED | U-1027: Reduction of elevated plasma sterol and/or stanol levels in a mammal U-1173: To reduce elevated total-c, LDL-c, apo b and non-HDL-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate |
EVAMIST (SPRAY) (TRANSDERMAL) ESTRADIOL
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant: PADAGIS US NDA No.: 022014 Prod. No.: 001 RX (1.53MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6978945 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 001: None | Jul 31, 2022 |
ADDYI (TABLET) (ORAL) FLIBANSERIN
Drug Classes: Sexual Disorder Agents:Sexual Disorder Agents (Female)
NDA Applicant: SPROUT PHARMS NDA No.: 022526 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7420057 DS* DP* Stable polymorph of flibanserin Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 14, 2015 | Aug 1, 2022 | |
| Pat. No. 9468639 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 8, 2016 | Oct 16, 2022 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Pat. No. 7151103 Method of treating female hypoactive sexual desire disorder with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
| Pat. No. 8227471 Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 | May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
MACRILEN (FOR SOLUTION) (ORAL) MACIMORELIN ACETATE
Drug Classes: growth hormone (GH) secretagogue receptor agonist
NDA Applicant: NOVO NDA No.: 205598 Prod. No.: 001 RX (EQ 60MG BASE/POUCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6861409 DS* DP* Growth hormone secretagogues Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Aug 1, 2022 | U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin |
| Pat. No. 8192719 Methods and kits to diagnose growth hormone deficiency by oral administration of EP 1572 or EP 1573 compounds Claim Types: Diagnostic or surgical method; Kit Pat. Sub. Date(s): 001: Jan 19, 2018 | Oct 12, 2027 | U-2220: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 20, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 20, 2024 | ODE-170: For the diagnosis of adult growth hormone deficiency (AGHD) |
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 022304 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2011 | Aug 5, 2022 | U-931: Relief of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None | Jun 27, 2025 | U-931: Relief of moderate to severe acute pain |
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 203794 Prod. No.: 001 DISC (EQ 20MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 5, 2022 | U-1289: Management of moderate to severe acute pain |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Jun 27, 2025 | U-1289: Management of moderate to severe acute pain |
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC NDA No.: 200533 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)] 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 19, 2011; 002: None; 003: None; 004: None; 005: None | Aug 5, 2022 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 11007156 DP* Prolonged release pharmaceutical composition containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 17, 2021 | Oct 22, 2022 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8075872 DP* Abuse-proofed dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8420056 DP* Abuse-proofed dosage form Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None | Nov 20, 2023 | |
| Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None | Oct 10, 2024 | |
| Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None | Jun 27, 2025 | U-1178: Relief of moderate to severe chronic pain U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
| Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Sep 22, 2028 | U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy |
DUAKLIR PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA NDA No.: 210595 Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Aug 7, 2022 | |
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Apr 22, 2027 | |
| Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Mar 29, 2022 |
TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: ASTRAZENECA NDA No.: 202450 Prod. No.: 001 RX (0.4MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Aug 7, 2022 | |
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Jun 28, 2017 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Apr 22, 2027 | |
| Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Oct 26, 2018 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 29, 2022 | M-256: Information added to the clinical studies section to fulfill a post-marketing requirement |
KINEVAC (INJECTABLE) (INJECTION) SINCALIDE
Drug Classes: cholecystokinin (CCK) analog
NDA Applicant: BRACCO NDA No.: 017697 Prod. No.: 001 RX (0.005MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6803046 DP* Sincalide formulations Claim Types: Formulation; Process; Kit; Method of use Pat. Sub. Date(s): 001: None | Aug 16, 2022 |
AFINITOR (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Immunological Agents:Immunosuppressants == kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS NDA No.: 022334 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004 RX (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 | Aug 18, 2022 *PED | U-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. |
| Pat. No. 8436010 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jun 3, 2013 | Aug 22, 2022 *PED | U-1396: Treatment of advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole |
| Pat. No. 8410131 Cancer treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2013 | May 1, 2026 *PED | U-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib |
| Pat. No. 9006224 Neuroendocrine tumor treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 20, 2015 | Jul 1, 2028 | U-1681: Treatment of patients with progessive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2023 | ODE-108: Treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, (excluding pancreatic) with unresectable, locally advanced or metastatic disease |
AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Immunological Agents:Immunosuppressants == kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM NDA No.: 203985 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 | Aug 18, 2022 *PED | U-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. U-2280: Adjunctive treatment of patients with TSC-associated partial-onset seizures |
| Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 | Mar 27, 2023 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 10, 2021 | I-773: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2025 | ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
LEVAQUIN (SOLUTION) (ORAL) LEVOFLOXACIN [Has competitive generic]
Drug Classes: Antibacterials:Quinolones == Ophthalmic Agents:Ophthalmic Anti-Infectives == quinolone antimicrobial
NDA Applicant: JANSSEN PHARMS NDA No.: 021721 Prod. No.: 001 DISC (250MG/10ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6806256 DP* Taste masked liquid pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 26, 2022 *PED |
BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
NDA Applicant: ALBIREO NDA No.: 215498 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7132416 DS* DP* Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia Claim Types: Compound; Process; Composition Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Sep 5, 2022 | |
| Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10981952 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10975046 DS* Crystal modifications of odevixibat Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Jun 20, 2039 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 20, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 20, 2028 | ODE-363: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC) |
DEXYCU KIT (SUSPENSION) (INTRAOCULAR) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: EYEPOINT PHARMS NDA No.: 208912 Prod. No.: 001 RX (9%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7560120 DP* Vehicles for delivery of biologically active substances Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 5, 2018 | Sep 5, 2022 | |
| Pat. No. 6960346 DP* Vehicles for delivery of biologically active substances Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 5, 2018 | Jul 3, 2023 | |
| Pat. No. 10799642 DP* Dose guides for injection syringe Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Jun 11, 2021 | May 11, 2032 | |
| Pat. No. 10028965 Use of sustained release dexamethasone in post-cataract surgery inflammation Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 3, 2018 | May 23, 2034 | U-2340: Treatment of postoperative inflammation |
| Pat. No. 10159683 DP* Use of sustained release dexamethasone in post-cataract surgery inflammation Claim Types: Kit; Formulation Pat. Sub. Date(s): 001: Jan 23, 2019 | May 23, 2034 | |
| Pat. No. 10022502 Dose guides for injection syringe Claim Types: Device Pat. Sub. Date(s): 001: Aug 3, 2018 | Jun 22, 2034 | U-2340: Treatment of postoperative inflammation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 9, 2021 |
LONHALA MAGNAIR KIT (SOLUTION) (INHALATION) GLYCOPYRROLATE
Drug Classes: Gastrointestinal Agents:Antispasmodics, Gastrointestinal == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: SUNOVION RESP NDA No.: 208437 Prod. No.: 001 RX (25MCG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7316067 DP* Forming a perforate membrane by laser drilling and a subsequent electro-polishing step Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 2, 2018 | Sep 6, 2022 | |
| Pat. No. 8511581 DP* Fluid droplet production apparatus and method Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 8, 2023 | |
| Pat. No. 7458372 DP* Inhalation therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 18, 2024 | |
| Pat. No. 7931212 DP* Fluid droplet production apparatus and method Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Nov 25, 2025 | |
| Pat. No. 9265900 DP* Disposable ampoule for an aerosol generating device Claim Types: Drug in a container; Product-by-process; Method of use Pat. Sub. Date(s): 001: Jan 2, 2018 | Dec 7, 2028 | |
| Pat. No. 10940110 DP* Method and system for the treatment of chronic COPD with nebulized anticholinergic administrations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2021 | Feb 26, 2029 | U-1773: Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9789270 DP* Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | Oct 30, 2030 | |
| Pat. No. 9168556 DP* Membrane nebulizer and method for welding a membrane to a carrier during the production of a membrane nebulizer Claim Types: Device; Process Pat. Sub. Date(s): 001: Jan 2, 2018 | Sep 1, 2032 | |
| Pat. No. 9604018 DP* Aerosol therapy device Claim Types: Device Pat. Sub. Date(s): 001: Jan 2, 2018 | May 16, 2033 | |
| Pat. No. 10376661 DP* Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Sep 5, 2019 | Sep 14, 2035 | |
| Pat. No. 10688518 DP* Method of manufacturing a vibratable head for an aerosol generator and vibratable head for an aerosol generator Claim Types: Part of a dosage form; Device; Process Pat. Sub. Date(s): 001: Jun 30, 2020 | Nov 12, 2036 | |
| Pat. No. 10744277 DP* Aerosol delivery device and method of operating the aerosol delivery device Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 1, 2020 | Dec 7, 2036 | U-2941: A method of using an aerosol delivery device to aerosolize glycopyrrolate for the treatment of chronic obstructive pulmonary disease (COPD) |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 203975 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7776895 DP* Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Sep 11, 2022 | |
| Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: May 14, 2014 | Mar 23, 2023 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7498440 DS* DP* Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | |
| Pat. No. 8309572 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 9, 2014 | Apr 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 7439393 DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | May 21, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8183257 Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jul 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 8511304 DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 | Jun 14, 2027 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Pat. No. 9333310 DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 | Oct 2, 2027 | |
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Oct 23, 2027 | |
| Pat. No. 7488827 DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 9, 2014 | Dec 18, 2027 | |
| Pat. No. 8161968 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Feb 5, 2028 | |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 | Mar 8, 2030 | |
| Pat. No. 8746242 DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 | Oct 11, 2030 | |
| Pat. No. 9750726 DP* Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 | Nov 29, 2030 | |
| Pat. No. 11090294 Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2021 | Nov 29, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 9, 2022 | M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial |
ORAVIG (TABLET) (BUCCAL) MICONAZOLE
Drug Classes: Antifungals == azole antifungal
NDA Applicant: GALT PHARMS NDA No.: 022404 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916485 DP* Prolonged release bioadhesive therapeutic systems Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2022 | U-1051: Treatment of oropharyngeal candidiasis |
| Pat. No. 7651698 Prolonged release bioadhesive therapeutic systems Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 11, 2022 | U-1051: Treatment of oropharyngeal candidiasis |
| Pat. No. 8518442 DP* Prolonged release bioadhesive therapeutic systems Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 17, 2013 | Sep 11, 2022 |
CIPRODEX (SUSPENSION/DROPS) (OTIC) CIPROFLOXACIN; DEXAMETHASONE [GENERIC AB]
Drug Classes: Antibacterials:Quinolones == Ophthalmic Agents:Ophthalmic Anti-Infectives == Otic Agents:Otic Anti-Infectives == Otic Agents:Otic Combinations == quinolone antimicrobial == Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: NOVARTIS NDA No.: 021537 Prod. No.: 001 RX (0.3%;0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9149486 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 2, 2015 | Sep 13, 2022 | U-1578: Treatment of acute otitis media |
| Pat. No. 9345714 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2016 | Sep 13, 2022 | U-1578: Treatment of acute otitis media |
| Pat. No. 9402805 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Sep 13, 2022 | U-1578: Treatment of acute otitis media U-1679: Treatment of acute otitis externa |
| Pat. No. 8846650 DP* Method of treating middle ear infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 3, 2014 | Jun 4, 2025 | U-1578: Treatment of acute otitis media |
VAGIFEM (TABLET) (VAGINAL) ESTRADIOL [GENERIC AB]
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant: NOVO NORDISK INC NDA No.: 020908 Prod. No.: 002 RX (10MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7018992 Hormone composition Claim Types: Method of use Pat. Sub. Date(s): 002: None | Sep 17, 2022 | U-1023: Treatment of atrophic vaginitis due to menopause |
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 202611 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6346532 DS* DP* [Extended 1259 days (3.4 years)] Amide derivatives or salts thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | Sep 27, 2022 *PED | |
| Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 16, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | May 4, 2024 *PED | |
| Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | May 4, 2024 *PED | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 17, 2018 | Apr 30, 2029 *PED | U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 10842780 DP* Pharmaceutical composition for modified release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2020 | Mar 28, 2030 *PED | U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 27, 2021 | I-777: Co-administration therapy of mirabegron with solifenacin succinate for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Exclusivity Code: I - New Indication | Sep 25, 2024 PED | I-855: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 3 years and older and weighing 35 kilograms or more |
MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 213801 Prod. No.: 001 RX (8MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6346532 DS* [Extended 1259 days (3.4 years)] Amide derivatives or salts thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 22, 2021 | Sep 27, 2022 *PED | |
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Apr 22, 2021 | May 4, 2024 *PED | |
| Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 22, 2021 | Oct 1, 2036 *PED | U-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 25, 2024 PED |
TRINTELLIX (TABLET) (ORAL) VORTIOXETINE HYDROBROMIDE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 204447 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 204447 Prod. No.: 003 DISC (EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8476279 DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2013 | Oct 2, 2022 | U-1439: Method of treating an affective disorder such as depression |
| Pat. No. 7144884 DS* DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2013 | Jun 17, 2026 | U-1439: Method of treating an affective disorder such as depression |
| Pat. No. 8969355 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 19, 2015 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9125908 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125909 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125910 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Jun 15, 2027 | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9227946 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2016 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9861630 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 18, 2018 | Jun 15, 2027 | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 8722684 DS* DP* 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process; Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Jun 30, 2031 | |
| Pat. No. 9278096 Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 13, 2018 | Mar 21, 2032 | U-2436: Use in the treatment of major depressive disorder to improve treatment emergent sexual dysfunction (TESD) induced by prior serotonin reuptake inhibitor treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 22, 2024 | M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling |
| Exclusivity Code: M - Miscellaneous | May 2, 2021 | M-227: Addition to the clinical studies section of the labeling with the subsection entitled digit symbol substitution test in major depressive disorder |
| Exclusivity Code: M - Miscellaneous | Oct 19, 2021 | M-234: Update to the prescribing information for vortioxetine on treatment-emergent sexual dysfunction comparing vortioxetine and SSRIS |
| Exclusivity Code: M - Miscellaneous | Nov 13, 2023 | M-267: Information added to the labeling regarding the result of study LUAA21004-402 |
MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations == angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8003679 Use of inhibitors of the renin-angiotensin system Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2011 | Oct 6, 2022 | U-1176: Treatment or prevention of stroke |
AVANDAMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == biguanide == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 001 DISC (500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 002 DISC (500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 003 DISC (500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 004 DISC (1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 005 DISC (1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8236345 DP* Composition and use Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None | Oct 7, 2022 |
LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA NDA No.: 213716 Prod. No.: 001 RX (7.9MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332472 DS* DP* Cyclosporine analogue mixtures and their use as immunomodulating agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 11, 2021 | Oct 17, 2022 | U-3056: Treatment of patients with active lupus nephritis |
| Pat. No. 10286036 Protocol for treatment of lupus nephritis Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Feb 11, 2021 | Dec 7, 2037 | U-3056: Treatment of patients with active lupus nephritis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 22, 2026 |
WELCHOL (TABLET) (ORAL) COLESEVELAM HYDROCHLORIDE [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Cardiovascular Agents:Dyslipidemics, Other == bile acid sequestrant
NDA Applicant: DAIICHI SANKYO NDA No.: 021176 Prod. No.: 001 RX (625MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 17, 2022 *PED | U-851: Treatment of Type 2 diabetes mellitus |
WELCHOL (FOR SUSPENSION) (ORAL) COLESEVELAM HYDROCHLORIDE [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Cardiovascular Agents:Dyslipidemics, Other == bile acid sequestrant
NDA Applicant: DAIICHI SANKYO NDA No.: 022362 Prod. No.: 002 RX (3.75GM/PACKET) NDA No.: 022362 Prod. No.: 001 DISC (1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7229613 Method for lowering serum glucose Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Oct 17, 2022 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 20, 2024 | M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies |
MOVANTIK (TABLET) (ORAL) NALOXEGOL OXALATE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == opioid antagonist
NDA Applicant: REDHILL NDA No.: 204760 Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7662365 DS* DP* Polymer conjugates of opioid antagonists Claim Types: Composition; Compound Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Oct 18, 2022 | |
| Pat. No. 8617530 Polymer conjugates of opioid antagonists Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Oct 18, 2022 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 7056500 DP* Polymer conjugates of opioid antagonists Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2015 | Jun 29, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 8067431 Chemically modified small molecules Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Dec 16, 2024 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. 7786133 DS* DP* Chemically modified small molecules Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Sep 16, 2028 | |
| Pat. No. 9012469 DS* DP* Crystalline naloxol-peg conjugate Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: May 15, 2015 | Apr 2, 2032 |
SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO VENTURES LTD NDA No.: 022239 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8343130 DP* Needleless injector Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 25, 2013 | Oct 18, 2022 | |
| Pat. No. 8241244 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Process Pat. Sub. Date(s): 001: Aug 31, 2012 | Nov 21, 2022 | |
| Pat. No. 8491524 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 23, 2013 | Nov 21, 2022 | |
| Pat. No. 8267903 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Oct 10, 2012 | Mar 18, 2023 | |
| Pat. No. 8118771 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Process Pat. Sub. Date(s): 001: Mar 9, 2012 | Aug 10, 2023 | |
| Pat. No. 8241243 DP* Needleless injector drug capsule and a method for filling thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2012 | Aug 10, 2023 | |
| Pat. No. 8287489 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Nov 16, 2012 | Dec 6, 2024 | |
| Pat. No. 7901385 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Mar 23, 2011 | Jul 31, 2026 | |
| Pat. No. 7776007 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 4, 2011 | Nov 22, 2026 |
HALFLYTELY (FOR SOLUTION, TABLET, DELAYED RELEASE) (ORAL) BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == osmotic laxative
NDA Applicant: BRAINTREE NDA No.: 021551 Prod. No.: 003 DISC (5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7291324 Method of bowel cleansing Claim Types: Method of use Pat. Sub. Date(s): 003: None | Oct 22, 2022 | U-837: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults |
SINGULAIR (GRANULE) (ORAL) MONTELUKAST SODIUM [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Antileukotrienes == leukotriene receptor antagonist (LTRA)
NDA Applicant: MERCK NDA No.: 021409 Prod. No.: 001 RX (EQ 4MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8007830 DP* Granule formation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2011 | Oct 24, 2022 |
TRI-LUMA (CREAM) (TOPICAL) FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Dermatological Agents:Dermatological Agents, Other == Otic Agents:Otic Glucocorticoids == corticosteroid == melanin synthesis inhibitor == Antineoplastics:Retinoids == Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: GALDERMA LABS LP NDA No.: 021112 Prod. No.: 001 RX (0.01%;4%;0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8247395 DP* Topical skin care composition Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 5, 2012 | Oct 25, 2022 | |
| Pat. No. 8653053 DP* Topical skin care composition Claim Types: Product-by-process; Formulation Pat. Sub. Date(s): 001: Mar 14, 2014 | Oct 25, 2022 | |
| Pat. No. 7915243 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 31, 2011 | Sep 8, 2023 | |
| Pat. No. 7939516 DP* Topical skin care composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 17, 2011 | Sep 8, 2023 |
RYDAPT (CAPSULE) (ORAL) MIDOSTAURIN
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 207997 Prod. No.: 001 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No |