Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec.156 and pediatric (PED) extensions.
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10980803 Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function Pat. Sub. Date(s): All strengths: May 19, 2021 Claim Types: Method of use Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia Use Code: U-543: Treatment of schizophrenia | Sep 24, 2033 | New patent for this product |
ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Pat. Sub. Date(s): All strengths: Mar 18, 2021 Claim Types: Device; Method of administration | Dec 14, 2035 | New patent for this product |
AUBAGIO (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: pyrimidine synthesis inhibitor
NDA Applicant: SANOFI AVENTIS US NDA No.: 202992 Prod. No.: 001 RX (7MG); 002 RX (14MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-61: Revisions to labeling based on data submitted in response to pediatric written request | Oct 30, 2024 PED | New exclusivity for this product |
AZSTARYS (CAPSULE) (ORAL) DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Drug Classes: central nervous system stimulant
NDA Applicant: COMMAVE THERAP NDA No.: 212994 Prod. No.: 001 RX (EQ 5.2MG BASE;EQ 26.1MG BASE); 002 RX (EQ 7.8MG BASE;EQ 39.2MG BASE); 003 RX (EQ 10.4MG BASE;EQ 52.3MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9079928 DP* Methylphenidate-oxoacid conjugates, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Composition | Jul 27, 2032 | New product in Orange Book |
| Pat. No. 10584112 DS* DP* Methylphenidate-prodrugs, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Compound; Composition | Dec 9, 2037 | New product in Orange Book |
| Pat. No. 10584113 DP* Methylphenidate-prodrugs, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Composition | Dec 9, 2037 | New product in Orange Book |
| Pat. No. 10759778 DP* Methylphenidate-prodrugs, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Kit | Dec 9, 2037 | New product in Orange Book |
| Pat. No. 10858341 Compositions comprising methylphenidate-prodrugs, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Method of use Use Code: U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate | Dec 9, 2037 | New product in Orange Book |
| Pat. No. 10954213 Compositions comprising methylphenidate-prodrugs, processes of making and using the same Pat. Sub. Date(s): All strengths: May 17, 2021 Claim Types: Method of use Use Code: U-3094: Treatment of attention-deficit hyperactivity disorder (ADHD) with serdexmethylphenidate and dexmethylphenidate | Dec 9, 2037 | New product in Orange Book |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | May 7, 2026 | New product in Orange Book |
BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
NDA Applicant: ASCEND THERAPS US NDA No.: 202344 Prod. No.: 001 RX (EQ 70MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9592195 DP* Stable effervescent bisphosphonate formulations with rapid solubilization characteristics Pat. Sub. Date(s): 001: May 12, 2021 Claim Types: Formulation | Dec 5, 2031 | New patent for this product |
BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
NDA Applicant: BEIGENE NDA No.: 213217 Prod. No.: 001 RX (80MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10570139 DS* DP* Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 4, 2021 Claim Types: Method of use Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy | Apr 22, 2034 | New patent for this product |
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA NDA No.: 212295 Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Oct 6, 2025 | New expiration date. Was previously Jul 2, 2025 |
CALCITONIN-SALMON (INJECTABLE) (INJECTION) CALCITONIN SALMON [GENERIC AP]
Drug Classes: calcitonin
NDA Applicant: CUSTOPHARM INC NDA No.: 212416 Prod. No.: 001 RX (200 IU/ML)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Nov 10, 2021 | New product in Orange Book |
CARBAGLU (TABLET, FOR SUSPENSION) (ORAL) CARGLUMIC ACID
Drug Classes: Carbamoyl Phosphate Synthetase 1 (CPS 1) activator
NDA Applicant: RECORDATI RARE NDA No.: 022562 Prod. No.: 001 RX (200MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-345: In pediatric and adult patients as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) | Jan 22, 2028 | New exclusivity for this product |
CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE NDA No.: 020866 Prod. No.: 001 RX (EQ 0.8MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11000522 Bromocriptine formulations Pat. Sub. Date(s): 001: Jun 3, 2021 Claim Types: Formulation claimed by its inherent performace characteristics Use Code: U-3119: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 11 Use Code: U-3120: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 11, and 12 Use Code: U-3121: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13 and 23 Use Code: U-3122: Adjunct to diet exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 13, 23, and 24 | Apr 30, 2032 | New patent for this product |
DIOVAN (TABLET) (ORAL) VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 021283 Prod. No.: 001 RX (80MG); 002 RX (160MG); 004 RX (40MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Apr 19, 2024 | New exclusivity for this product |
DOCETAXEL (INJECTABLE) (INJECTION) DOCETAXEL [GENERIC AP]
Drug Classes: microtubule inhibitor
NDA Applicant: SHILPA NDA No.: 205934 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (80MG/4ML (20MG/ML)); 003 RX (160MG/8ML (20MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10842770 DP* Non-aqueous taxane pro-emulsion formulations and methods of making and using the same Pat. Sub. Date(s): All strengths: Dec 15, 2020 Claim Types: Formulation; Method of administration; Kit Use Code: U-2998: Method of administering docetaxel to a subject combining the docetaxel pro-emulsion formulation with an aqueous medium to produce docetaxel emulsion | Aug 7, 2031 | New expiration date. Was previously Aug 4, 2031 |
EMPAVELI (SOLUTION) (SUBCUTANEOUS) PEGCETACOPLAN
NDA Applicant: APELLIS PHARMS NDA No.: 215014 Prod. No.: 001 RX (1080MG/20ML (54MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7888323 DS* Potent compstatin analogs Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound | Dec 4, 2027 | New product in Orange Book |
| Pat. No. 7989589 DS* Compstatin analogs with improved activity Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound | Dec 4, 2027 | New product in Orange Book |
| Pat. No. 9169307 DS* Potent compstatin analogs Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound; Process; Method of use Use Code: U-3123: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of complement inhibitor pegcetacoplan | Nov 18, 2027 | New product in Orange Book |
| Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound | Nov 15, 2033 | New product in Orange Book |
| Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound | Aug 2, 2033 | New product in Orange Book |
| Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Pat. Sub. Date(s): 001: Jun 9, 2021 Claim Types: Compound; Method of use Use Code: U-3124: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh) by administration of pegcetacoplan | Nov 15, 2033 | New product in Orange Book |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-351: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) | May 14, 2028 | New product in Orange Book |
EPCLUSA (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208341 Prod. No.: 001 RX (400MG;100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8575135 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 15, 2016 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 8735372 Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 001: Jul 15, 2016 Claim Types: Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 8921341 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 15, 2016 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 8940718 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 15, 2016 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 9757406 DP* Combination formulation of two antiviral compounds Pat. Sub. Date(s): 001: Sep 26, 2017 Claim Types: Formulation | Jul 30, 2034 *PED | New expiration date. Was previously Jan 30, 2034 |
| Pat. No. 10086011 Combination formulation of two antiviral compounds Pat. Sub. Date(s): 001: Oct 23, 2018 Claim Types: Method of use Use Code: U-1470: For the treatment of hepatitis C | Jul 30, 2034 *PED | New expiration date. Was previously Jan 30, 2034 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: D - New Dosing Schedule: D-177: Information added to the dosing section in regard to the treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysis | May 15, 2023 PED | New expiration date. Was previously Nov 15, 2022 |
| Exclusivity Code: M - Miscellaneous: M-264: Information added to the labeling describing a phase 2, multicenter, open-label study to evaluate the safety/efficacy of sofosbuvir/velpatasvir in subjects with chronic HCV infection who have received a liver transplant | Jan 14, 2024 PED | New expiration date. Was previously Jul 14, 2023 |
| Exclusivity Code: NPP - New patient population | Sep 19, 2023 PED | New expiration date. Was previously Mar 19, 2023 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-293: Tx of ped pts 6 yrs of age & older or weighing at least 17 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin | Sep 19, 2027 PED | New expiration date. Was previously Mar 19, 2027 |
EPCLUSA (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC NDA No.: 208341 Prod. No.: 002 RX (200MG;50MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7964580 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use; Process; Product-by-process Use Code: U-1470: For the treatment of hepatitis C | Sep 26, 2029 *PED | New expiration date. Was previously Mar 26, 2029 |
| Pat. No. 8334270 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 8575135 DS* DP* Antiviral compounds Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 8580765 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use; Process Use Code: U-1470: For the treatment of hepatitis C | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 8618076 DS* DP* Nucleoside phosphoramidates Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-1470: For the treatment of hepatitis C | Jun 11, 2031 *PED | New expiration date. Was previously Dec 11, 2030 |
| Pat. No. 8633309 DS* DP* Nucleoside phosphoramidates Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 26, 2029 *PED | New expiration date. Was previously Mar 26, 2029 |
| Pat. No. 8735372 Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 8889159 DP* Compositions and methods for treating hepatitis C virus Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Composition; Formulation; Process; Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 26, 2029 *PED | New expiration date. Was previously Mar 26, 2029 |
| Pat. No. 8921341 DS* DP* Antiviral compounds Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 8940718 DS* DP* Antiviral compounds Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 9085573 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-1470: For the treatment of hepatitis C | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 9284342 DS* DP* Nucleoside phosphoramidates Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-1470: For the treatment of hepatitis C | Mar 13, 2031 *PED | New expiration date. Was previously Sep 13, 2030 |
| Pat. No. 9757406 DP* Combination formulation of two antiviral compounds Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Formulation | Jul 30, 2034 *PED | New expiration date. Was previously Jan 30, 2034 |
| Pat. No. 10086011 Combination formulation of two antiviral compounds Pat. Sub. Date(s): 002: Apr 16, 2020 Claim Types: Method of use Use Code: U-1470: For the treatment of hepatitis C | Jul 30, 2034 *PED | New expiration date. Was previously Jan 30, 2034 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: M - Miscellaneous: M-264: Information added to the labeling describing a phase 2, multicenter, open-label study to evaluate the safety/efficacy of sofosbuvir/velpatasvir in subjects with chronic HCV infection who have received a liver transplant | Jan 14, 2024 PED | New expiration date. Was previously Jul 14, 2023 |
| Exclusivity Code: NS - New strength | Sep 19, 2023 PED | New expiration date. Was previously Mar 19, 2023 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-293: Tx of ped pts 6 yrs of age & older or weighing at least 17 kg with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin | Sep 19, 2027 PED | New expiration date. Was previously Mar 19, 2027 |
ERIVEDGE (CAPSULE) (ORAL) VISMODEGIB
Drug Classes: hedgehog pathway inhibitor
NDA Applicant: GENENTECH NDA No.: 203388 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9790183 Pyridyl inhibitors of hedgehog signalling Pat. Sub. Date(s): 001: May 19, 2021 Claim Types: Method of use Use Code: U-3109: Method of using vismodegib to treat basal cell carcinoma | Sep 2, 2025 | New patent for this product |
EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: KALA PHARMS INC NDA No.: 210933 Prod. No.: 001 RX (0.25%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10993908 Compositions and methods for ophthalmic and/or other applications Pat. Sub. Date(s): 001: May 26, 2021 Claim Types: Method of administration Use Code: U-3117: Administration to the eye of a patient for treatment of dry eye condition | May 3, 2033 | New patent for this product |
FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB NDA No.: 202293 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression | Apr 30, 2024 | New exclusivity for this product |
FERRIPROX (TABLET) (ORAL) DEFERIPRONE [GENERIC AB]
Drug Classes: iron chelator
NDA Applicant: CHIESI NDA No.: 021825 Prod. No.: 001 RX (500MG); 002 RX (1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7049328 Use for deferiprone Pat. Sub. Date(s): 001: Oct 8, 2015; 002: Jan 31, 2020 Claim Types: Method of use; Method of administration Use Code: U-3083: Method of treating transfusional iron overload | Jun 28, 2021 | New Use Code |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemias | Apr 30, 2024 | New exclusivity for this product |
FERRIPROX (SOLUTION) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: CHIESI NDA No.: 208030 Prod. No.: 001 RX (100MG/ML); 002 RX (80MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7049328 Use for deferiprone Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019 Claim Types: Method of use; Method of administration Use Code: U-3083: Method of treating transfusional iron overload | Jun 28, 2021 | New Use Code |
| Pat. No. 8703156 DP* Liquid formulation for deferiprone with palatable taste Pat. Sub. Date(s): 001: Oct 6, 2015; 002: Jan 31, 2019 Claim Types: Formulation; Method of use Use Code: U-3083: Method of treating transfusional iron overload | Oct 26, 2029 | New expiration date. Was previously Oct 29, 2029; New Use Code |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemias | Apr 30, 2024 | New exclusivity for this product |
FERRIPROX (TABLET) (ORAL) DEFERIPRONE
Drug Classes: iron chelator
NDA Applicant: CHIESI NDA No.: 212269 Prod. No.: 001 RX (1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7049328 Use for deferiprone Pat. Sub. Date(s): 001: Jun 16, 2020 Claim Types: Method of use; Method of administration Use Code: U-3083: Method of treating transfusional iron overload Use Code: U-735: Method of treating chronic iron overload | Jun 28, 2021 | New Use Code |
| Pat. No. 10780055 DP* Delayed release deferiprone tablets and methods of using the same Pat. Sub. Date(s): 001: Oct 7, 2020 Claim Types: Formulation; Method of use Use Code: U-3083: Method of treating transfusional iron overload Use Code: U-735: Method of treating chronic iron overload | Oct 25, 2038 | New Use Code |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-859: Treatment of patients with transfusional iron overload due to sickle cell disease or other anemias | Apr 30, 2024 | New exclusivity for this product |
FYCOMPA (TABLET) (ORAL) PERAMPANEL [GENERIC AB]
Drug Classes: 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 | Change |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Pat. Sub. Date(s): All strengths: Nov 19, 2012 Claim Types: Compound; Composition; Method of use Use Code: U-106: Treatment of epilepsy Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older | Jun 8, 2022 | New expiration date. Was previously Jun 8, 2021 |
FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: EISAI INC NDA No.: 208277 Prod. No.: 001 RX (0.5MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Pat. Sub. Date(s): 001: May 27, 2016 Claim Types: Compound; Composition; Method of use Use Code: U-106: Treatment of epilepsy Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older | Jun 8, 2022 | New expiration date. Was previously Jun 8, 2021 |
GIMOTI (SPRAY, METERED) (NASAL) METOCLOPRAMIDE HYDROCHLORIDE
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: EVOKE PHARMA INC NDA No.: 209388 Prod. No.: 001 RX (EQ 15MG BASE/SPRAY)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11020361 Nasal formulations of metoclopramide Pat. Sub. Date(s): 001: Jun 3, 2021 Claim Types: Method of use Use Code: U-2843: Nasal administration of metoclopramide for treatment of diabetic gastroparesis | Dec 22, 2029 | New patent for this product |
GOPRELTO (SOLUTION) (NASAL) COCAINE HYDROCHLORIDE
NDA Applicant: GENUS LIFESCIENCES NDA No.: 209963 Prod. No.: 001 RX (4%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10973811 Pharmaceutical compositions and methods of using the same Pat. Sub. Date(s): 001: May 13, 2021 Claim Types: Method of use Use Code: U-2226: Method of administering a local anesthetic to the mucous membranes in patients with renal impairment | Feb 7, 2037 | New patent for this product |
| Pat. No. 10987347 Pharmaceutical compositions and methods of using the same Pat. Sub. Date(s): 001: May 27, 2021 Claim Types: Method of use Use Code: U-2225: Method of administering a local anesthetic to the mucous membranes in patients with hepatic impairment | Feb 7, 2037 | New patent for this product |
INGREZZA (CAPSULE) (ORAL) VALBENAZINE TOSYLATE
Drug Classes: vesicular monoamine transporter 2 (VMAT2) inhibitor
NDA Applicant: NEUROCRINE NDA No.: 209241 Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE); 003 RX (EQ 60MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10993941 Methods for the administration of certain VMAT2 inhibitors Pat. Sub. Date(s): All strengths: May 19, 2021 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia | Oct 10, 2037 | New patent for this product |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8895612 Methods and compositions for administration of iron Pat. Sub. Date(s): 001: Dec 17, 2014 Claim Types: Method of use; Method of administration Use Code: U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. Use Code: U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less Use Code: U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less Use Code: U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less Use Code: U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less | Jan 8, 2027 | New Use Code |
| Pat. No. 10519252 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose Use Code: U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose Use Code: U-2711: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron Use Code: U-2712: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 750 mg of elemental iron Use Code: U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron Use Code: U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron | Oct 20, 2023 | This patent is no longer listed for this product |
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML)); 003 RX (1GM IRON/20ML (50MG IRON/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8895612 Methods and compositions for administration of iron Pat. Sub. Date(s): 002: Feb 2, 2021; 003: May 21, 2021 Claim Types: Method of use; Method of administration Use Code: U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. Use Code: U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less Use Code: U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less Use Code: U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less Use Code: U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less | Jan 8, 2027 | New Use Code |
| Pat. No. 10519252 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2709: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose Use Code: U-2710: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose Use Code: U-3048: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron Use Code: U-3049: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide 500 to 750 mg of elemental iron | Oct 20, 2023 | This patent is no longer listed for this product |
KIMYRSA (POWDER) (INTRAVENOUS) ORITAVANCIN DIPHOSPHATE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: MELINTA THERAP NDA No.: 214155 Prod. No.: 001 RX (EQ 1.2GM BASE/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Mar 12, 2024 | New exclusivity for this product |
KLOXXADO (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: HIKMA NDA No.: 212045 Prod. No.: 001 RX (8MG/SPRAY)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10722510 DP* Liquid naloxone spray Pat. Sub. Date(s): 001: May 19, 2021 Claim Types: Formulation; Method of use Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients | Aug 26, 2034 | New patent for this product |
| Pat. No. 10973814 DP* Liquid naloxone spray Pat. Sub. Date(s): 001: May 19, 2021 Claim Types: Formulation; Method of use Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients | Aug 26, 2034 | New patent for this product |
KYLEENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE NDA No.: 208224 Prod. No.: 001 RX (19.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): 001: May 25, 2021 Claim Types: Device | Apr 1, 2031 | New patent for this product |
LEXETTE (AEROSOL, FOAM) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: MAYNE PHARMA NDA No.: 210566 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10857159 DP* Halobetasol foam composition and method of use thereof Pat. Sub. Date(s): 001: Dec 11, 2020 Claim Types: Formulation | May 30, 2037 *PED | New expiration date. Was previously Nov 30, 2036 |
LORBRENA (TABLET) (ORAL) LORLATINIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER NDA No.: 210868 Prod. No.: 001 RX (25MG); 002 RX (100MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-349: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, excluding patients whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease | Mar 3, 2028 | New exclusivity for this product |
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 209394 Prod. No.: 001 RX (100MG;40MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Pat. Sub. Date(s): 001: Aug 29, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg | Jul 19, 2032 *PED | New expiration date. Was previously Jan 19, 2032 |
| Pat. No. 8937150 DS* DP* Anti-viral compounds Pat. Sub. Date(s): 001: Aug 29, 2017 Claim Types: Compound; Composition | Nov 18, 2032 *PED | New expiration date. Was previously May 18, 2032 |
| Pat. No. 9321807 DS* Crystal forms Pat. Sub. Date(s): 001: Aug 29, 2017 Claim Types: New polymorph, salt or hydrate; Process | Dec 5, 2035 *PED | New expiration date. Was previously Jun 5, 2035 |
| Pat. No. 9586978 Anti-viral compounds Pat. Sub. Date(s): 001: Aug 29, 2017 Claim Types: Method of use Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg | Dec 10, 2030 *PED | New expiration date. Was previously Jun 10, 2030 |
| Pat. No. 10028937 Anti-viral compounds Pat. Sub. Date(s): 001: Aug 24, 2018 Claim Types: Method of use Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg | Dec 10, 2030 *PED | New expiration date. Was previously Jun 10, 2030 |
| Pat. No. 10039754 Anti-viral compounds Pat. Sub. Date(s): 001: Sep 6, 2018 Claim Types: Method of use Use Code: U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg | Dec 10, 2030 *PED | New expiration date. Was previously Jun 10, 2030 |
| Pat. No. 10286029 Method for treating HCV Pat. Sub. Date(s): 001: May 31, 2019 Claim Types: Method of use Use Code: U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg | Sep 14, 2034 *PED | New expiration date. Was previously Mar 14, 2034 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: D - New Dosing Schedule: D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study | Mar 26, 2023 PED | New expiration date. Was previously Sep 26, 2022 |
| Exclusivity Code: M - Miscellaneous: M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection | Oct 10, 2023 PED | New expiration date. Was previously Apr 10, 2023 |
| Exclusivity Code: NCE - New chemical entity | Feb 3, 2023 PED | New expiration date. Was previously Aug 3, 2022 |
| Exclusivity Code: NPP - New patient population | Oct 30, 2022 PED | New expiration date. Was previously Apr 30, 2022 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Oct 30, 2026 PED | New expiration date. Was previously Apr 30, 2026 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both | Oct 30, 2026 PED | New expiration date. Was previously Apr 30, 2026 |
MIRENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE NDA No.: 021225 Prod. No.: 001 RX (52MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): 001: May 25, 2021 Claim Types: Device | Apr 1, 2031 | New patent for this product |
NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: FOREST LABS LLC NDA No.: 022525 Prod. No.: 001 RX (7MG); 002 RX (14MG); 003 RX (21MG); 004 RX (28MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-539: Treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: pediculicide
NDA Applicant: PARAPRO LLC NDA No.: 022408 Prod. No.: 001 RX (0.9%)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-858: For the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older | Apr 28, 2024 | New exclusivity for this product |
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE INC NDA No.: 211675 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 18, 2021 Claim Types: New polymorph, salt or hydrate; Process; Composition | Oct 17, 2036 | New patent for this product |
| Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 18, 2021 Claim Types: Formulation | Oct 17, 2036 | New patent for this product |
SKYLA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin; progestin-containing intrauterine device (IUD)
NDA Applicant: BAYER HLTHCARE NDA No.: 203159 Prod. No.: 001 RX (13.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): 001: May 25, 2021 Claim Types: Device | Apr 1, 2031 | New patent for this product |
SOLOSEC (GRANULE) (ORAL) SECNIDAZOLE
Drug Classes: nitroimidazole antimicrobial
NDA Applicant: LUPIN NDA No.: 209363 Prod. No.: 001 RX (2GM/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11000507 DP* Secnidazole for use in the treatment of bacterial vaginosis Pat. Sub. Date(s): 001: Jun 7, 2021 Claim Types: Method of use Use Code: U-2583: Treatment of bacterial vaginosis in adult women | Sep 4, 2035 | New patent for this product |
| Pat. No. 11000508 DP* Secnidazole for use in the treatment of trichomoniasis Pat. Sub. Date(s): 001: Jun 7, 2021 Claim Types: Method of use Use Code: U-2583: Treatment of bacterial vaginosis in adult women | Sep 4, 2035 | New patent for this product |
SOTYLIZE (SOLUTION) (ORAL) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: ARBOR PHARMS LLC NDA No.: 205108 Prod. No.: 001 RX (5MG/ML (5MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11013703 DP* Sotalol compositions and uses of the same Pat. Sub. Date(s): 001: May 26, 2021 Claim Types: Formulation | Apr 1, 2034 | New patent for this product |
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: INDIVIOR INC NDA No.: 209819 Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML)); 002 RX (300MG/1.5ML (200MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11000520 Buprenorphine dosing regimens Pat. Sub. Date(s): All strengths: May 20, 2021 Claim Types: Method of use Use Code: U-3111: Treating opioid use disorder | Nov 6, 2035 | New patent for this product |
TECFIDERA (CAPSULE, DELAYED RELEASE) (ORAL) DIMETHYL FUMARATE [GENERIC AB]
NDA Applicant: BIOGEN INC NDA No.: 204063 Prod. No.: 001 RX (120MG); 002 RX (240MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10994003 Dimethyl fumarate and vaccination regimens Pat. Sub. Date(s): All strengths: May 28, 2021 Claim Types: Method of use Use Code: U-3148: Method of treating relapsing forms of multiple sclerosis before and after administering an inactive vaccine | Mar 13, 2035 | New patent for this product |
| Pat. No. 11007166 Methods of treating multiple sclerosis Pat. Sub. Date(s): All strengths: May 28, 2021 Claim Types: Method of use Use Code: U-1384: Method of treating multiple sclerosis | Nov 16, 2035 | New patent for this product |
| Pat. No. 11007167 Methods of treating multiple sclerosis Pat. Sub. Date(s): All strengths: May 28, 2021 Claim Types: Method of use Use Code: U-1384: Method of treating multiple sclerosis | Nov 16, 2035 | New patent for this product |
TIBSOVO (TABLET) (ORAL) IVOSIDENIB
NDA Applicant: SERVIER NDA No.: 211192 Prod. No.: 001 RX (250MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10980788 Therapy for treating malignancies Pat. Sub. Date(s): 001: May 20, 2021 Claim Types: Method of use Use Code: U-3112: Treating newly diagnosed acute myelogenous leukemia (AML) characterized by the presence of a mutant allele of IDH1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal Use Code: U-3113: Treating relapsed/refractory acute myelogenous leukemia (AML) characterized by the presence of a mutant allele of IDH1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal | Jun 7, 2039 | New patent for this product |
TOVIAZ (TABLET, EXTENDED RELEASE) (ORAL) FESOTERODINE FUMARATE [GENERIC AB]
NDA Applicant: PFIZER NDA No.: 022030 Prod. No.: 001 RX (4MG); 002 RX (8MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6858650 DS* [Extended 1149 days (3.1 years)] Stable salts of novel derivatives of 3,3-diphenylpropylamines Pat. Sub. Date(s): All strengths: None Claim Types: Compound; Process; Method of use Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency | Jan 3, 2023 *PED | New expiration date. Was previously Jul 3, 2022 |
| Pat. No. 7807715 DP* Pharmaceutical compositions comprising fesoterodine Pat. Sub. Date(s): All strengths: None Claim Types: Formulation; Method of use Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency | Dec 7, 2027 *PED | New expiration date. Was previously Jun 7, 2027 |
| Pat. No. 8088398 DP* Pharmaceutical compositions comprising fesoterodine Pat. Sub. Date(s): All strengths: None Claim Types: Formulation; Method of use Use Code: U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency | Dec 7, 2027 *PED | New expiration date. Was previously Jun 7, 2027 |
| Pat. No. 8501723 DP* Pharmaceutical compositions comprising fesoterodine Pat. Sub. Date(s): All strengths: Aug 20, 2013 Claim Types: Formulation | Dec 7, 2027 *PED | New expiration date. Was previously Jun 7, 2027 |
TRUSELTIQ (CAPSULE) (ORAL) INFIGRATINIB PHOSPHATE
NDA Applicant: QED THERAP NDA No.: 214622 Prod. No.: 001 RX (25MG); 002 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8552002 DS* DP* Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): All strengths: Jun 8, 2021 Claim Types: Compound; Composition | Aug 25, 2029 | New product in Orange Book |
| Pat. No. 9067896 DS* Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof Pat. Sub. Date(s): All strengths: Jun 8, 2021 Claim Types: New polymorph, salt or hydrate | Dec 20, 2026 | New product in Orange Book |
| Pat. No. 10278969 DP* Pharmaceutical dosage forms Pat. Sub. Date(s): All strengths: Jun 8, 2021 Claim Types: Formulation | Dec 11, 2034 | New product in Orange Book |
TYMLOS (SOLUTION) (SUBCUTANEOUS) ABALOPARATIDE
Drug Classes: parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS HEALTH INC NDA No.: 208743 Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10996208 DP* Abaloparatide formulations and methods of testing, storing, modifying, and using same Pat. Sub. Date(s): 001: Jun 1, 2021 Claim Types: Formulation; Analytical method | Apr 30, 2038 | New patent for this product |
VELPHORO (TABLET, CHEWABLE) (ORAL) FERRIC OXYHYDROXIDE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: VIFOR FRESENIUS NDA No.: 205109 Prod. No.: 001 RX (EQ 500MG IRON)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9561251 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Mar 2, 2017 Claim Types: Formulation; Process; Product-by-process; Method of use Use Code: U-1468: Control of phosphorous levels in patients | Jul 23, 2030 *PED | New expiration date. Was previously Jan 23, 2030 |
| Pat. No. 10624855 DP* Pharmaceutical composition, comprising phosphate binder particles Pat. Sub. Date(s): 001: Apr 27, 2020 Claim Types: Formulation | May 26, 2035 *PED | New expiration date. Was previously Nov 26, 2034 |
| Pat. No. 10682376 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Jun 17, 2020 Claim Types: Formulation | May 13, 2029 *PED | New expiration date. Was previously Nov 13, 2028 |
| Pat. No. 10695367 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Jul 1, 2020 Claim Types: Formulation | May 13, 2029 *PED | New expiration date. Was previously Nov 13, 2028 |
| Pat. No. 10925896 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Mar 10, 2021 Claim Types: Formulation | May 13, 2029 *PED | New expiration date. Was previously Nov 13, 2028 |
| Pat. No. 10925897 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Mar 10, 2021 Claim Types: Formulation | May 13, 2029 *PED | New expiration date. Was previously Nov 13, 2028 |
| Pat. No. 10933090 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Mar 10, 2021 Claim Types: Formulation | May 13, 2029 *PED | New expiration date. Was previously Nov 13, 2028 |
| Pat. No. 11013761 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Jun 2, 2021 Claim Types: Formulation | May 13, 2029 *PED | New patent for this product |
| Pat. No. 11013762 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Jun 2, 2021 Claim Types: Formulation | May 13, 2029 *PED | New patent for this product |
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: BCL-2 inhibitor
NDA Applicant: ABBVIE INC NDA No.: 208573 Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Pat. Sub. Date(s): All strengths: May 24, 2021 Claim Types: Method of use; Dosaage regimen Use Code: U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week | Sep 6, 2033 | New patent for this product |
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS NDA No.: 206940 Prod. No.: 001 RX (75MG); 002 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations Pat. Sub. Date(s): All strengths: Jun 3, 2021 Claim Types: Formulation | Mar 14, 2033 | New patent for this product |
VOSEVI (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: GILEAD SCIENCES INC NDA No.: 209195 Prod. No.: 001 RX (400MG;100MG;100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8575135 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 28, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor | May 5, 2034 *PED | New expiration date. Was previously Nov 5, 2033 |
| Pat. No. 8735372 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): 001: Jul 28, 2017 Claim Types: Method of use Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor | Sep 21, 2028 *PED | New expiration date. Was previously Mar 21, 2028 |
| Pat. No. 8921341 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 28, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
| Pat. No. 8940718 DS* DP* Antiviral compounds Pat. Sub. Date(s): 001: Jul 28, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-2039: Treatment of adult patients with chronic hcv infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an NS5A inhibitor Use Code: U-2040: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an NS5A inhibitor | May 16, 2033 *PED | New expiration date. Was previously Nov 16, 2032 |
VYLEESI (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) BREMELANOTIDE ACETATE
NDA Applicant: PALATIN TECHNOLOGIES NDA No.: 210557 Prod. No.: 001 RX (EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6794489 DS* DP* Compositions and methods for treatment of sexual dysfunction Pat. Sub. Date(s): 001: Jul 10, 2019 Claim Types: Composition; Method of use; Compound; Kit | Jun 28, 2025 | New expiration date. Was previously Jun 28, 2021 |
VYONDYS 53 (SOLUTION) (INTRAVENOUS) GOLODIRSEN
NDA Applicant: SAREPTA THERAPS INC NDA No.: 211970 Prod. No.: 001 RX (100MG/2ML (50MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10968450 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof Pat. Sub. Date(s): 001: Jun 1, 2021 Claim Types: Compound; Composition | Jun 28, 2025 | New patent for this product |
| Pat. No. 10995337 DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof Pat. Sub. Date(s): 001: Jun 1, 2021 Claim Types: Method of use; Composition Use Code: U-2675: Treatment of Duchenne muscular dystrophy (DMD) in patients having a confirmed mutation of the dmd gene that is amenable to exon 53 skipping | Jun 28, 2025 | New patent for this product |
VYXEOS (POWDER) (INTRAVENOUS) CYTARABINE; DAUNORUBICIN
Drug Classes: nucleoside metabolic inhibitor; anthracycline topoisomerase inhibitor
NDA Applicant: CELATOR PHARMS NDA No.: 209401 Prod. No.: 001 RX (100MG;44MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Mar 30, 2024 | New exclusivity for this product |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-350: Treatment of newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients ages 1 year and older | Mar 30, 2028 | New exclusivity for this product |
XADAGO (TABLET) (ORAL) SAFINAMIDE MESYLATE
Drug Classes: monoamine oxidase type B (MAO-B) inhibitor
NDA Applicant: MDD US NDA No.: 207145 Prod. No.: 001 RX (50MG); 002 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8283380 Methods for treatment of parkinson's disease Pat. Sub. Date(s): All strengths: Apr 20, 2017 Claim Types: Method of use Use Code: U-1993: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes | Mar 21, 2031 | New expiration date. Was previously Sep 1, 2027 |
XPOVIO (TABLET) (ORAL) SELINEXOR
NDA Applicant: KARYOPHARM THERAPS NDA No.: 212306 Prod. No.: 001 RX (20MG); 002 RX (40MG); 003 RX (50MG); 004 RX (60MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-346: For the treatment of adult patients with multiple myeloma who have received at least one prior therapy, excluding adult patients covered by XPOVIO's previous indication for multiple myeloma approved on July 3, 2019 | Dec 18, 2027 | New exclusivity for this product |
YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: anticholinergic
NDA Applicant: MYLAN IRELAND LTD NDA No.: 210598 Prod. No.: 001 RX (175MCG/3ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11008289 Crystalline freebase forms of a biphenyl compound Pat. Sub. Date(s): 001: May 20, 2021 Claim Types: Method of use Use Code: U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) | Jul 14, 2030 | New patent for this product |
ZEJULA (CAPSULE) (ORAL) NIRAPARIB TOSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: GLAXOSMITHKLINE NDA No.: 208447 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8071623 DS* DP* Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors Pat. Sub. Date(s): 001: Apr 24, 2017 Claim Types: Compound; Composition | Mar 27, 2031 | New expiration date. Was previously Mar 22, 2030 |
ZYKADIA (TABLET) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 211225 Prod. No.: 001 RX (150MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Apr 29, 2021 | New exclusivity for this product |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | May 26, 2024 | New exclusivity for this product |