BAQSIMI (POWDER) (NASAL) GLUCAGON
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist; antihypoglycemic agent; gastrointestinal motility inhibitor; glucagon-like peptide-2 (GLP-2) analog
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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Jul 24, 2022

CLOBEX (SHAMPOO) (TOPICAL) CLOBETASOL PROPIONATE [GENERIC AB]
Drug Classes: 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
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 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: 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: histamine-1 (H1) receptor antagonist; nonsteroidal anti-inflammatory drug
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

GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201292  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE)

Patents	Expiration	Patented Use
Pat. No. RE43431 DS* Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 1, 2013	Jan 22, 2022
Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 2, 2017	Nov 9, 2026	U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy
Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 1, 2013	Oct 10, 2029
Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process Pat. Sub. Date(s): All strengths: Oct 28, 2013	Dec 19, 2029
Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 2, 2018	Jul 5, 2030
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 12, 2021	I-763: Treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivity	Apr 15, 2023	ODE-115: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivity	Jan 12, 2025	ODE-230: First-line treatment of metastatic nonsmall cell lung cancer whose tumors have non-resistant epidermal growth factor mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivity	Jul 12, 2020	ODE-50: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

ESBRIET (TABLET) (ORAL) PIRFENIDONE
Drug Classes: 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: pyridone
NDA Applicant: GENENTECH INC      NDA No.: 208780  Prod. No.: 002 DISC (534MG**)

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: 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: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)

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: 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. 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jul 27, 2020	I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      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. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019	May 12, 2029
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. 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. 9577864 DP* Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017	Oct 3, 2033	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. 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jul 27, 2020	I-746: New indication of maintenance monotherapy treatment of bipolar I disorder in adults

VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV-1 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	May 7, 2022
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	Aug 15, 2032	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	Aug 15, 2032	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: NCE - New chemical entity	Nov 5, 2020

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH)

Patents	Expiration	Patented Use
Pat. No. 7967011 DP* Inhalation device Claim Types: Device Pat. Sub. Date(s): 001: None	Feb 11, 2022 *PED
Pat. No. 7759328 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: 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	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): 001: 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): 001: 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): 001: Dec 12, 2014	May 10, 2025 *PED
Pat. No. 7587988 DP* Inhaler device counter Claim Types: Device Pat. Sub. Date(s): 001: None	Oct 10, 2026 *PED
Pat. No. 8387615 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2013	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): 001: 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): 001: Jan 29, 2014	Oct 7, 2029 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Sep 11, 2020	M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - Miscellaneous	Dec 20, 2020	M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events
Exclusivity Code: NPP - New patient population	Jul 27, 2020 PED

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 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): 002: None	Feb 11, 2022 *PED
Pat. No. 7759328 DP* Composition for inhalation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 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. 8143239 DP* Composition for inhalation Claim Types: Device; Method of administration Pat. Sub. Date(s): 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): 002: 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): 002: 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): 002: Dec 12, 2014	May 10, 2025 *PED
Pat. No. 7587988 DP* Inhaler device counter Claim Types: Device Pat. Sub. Date(s): 002: None	Oct 10, 2026 *PED
Pat. No. 8387615 DP* Inhaler cap strap Claim Types: Device Pat. Sub. Date(s): 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): 002: 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): 002: Jan 29, 2014	Oct 7, 2029 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Sep 11, 2020	M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - Miscellaneous	Dec 20, 2020	M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events

SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: partial opioid agonist; 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. 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: 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**)

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: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS NA      NDA No.: 021566  Prod. No.: 001 DISC (30MG/VIAL**)

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: 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: 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. 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
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

PEPCID AC (TABLET, CHEWABLE) (ORAL) FAMOTIDINE
Drug Classes: 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: 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: 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: renin inhibitor; thiazide diuretic
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 001 RX (EQ 150MG BASE;12.5MG); 002 RX (EQ 150MG BASE;25MG); 003 RX (EQ 300MG BASE;12.5MG); 004 RX (EQ 300MG 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

FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: 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)**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML)**)

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: 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 3, 2020

VIMPAT (SOLUTION) (INTRAVENOUS) LACOSAMIDE
Drug Classes: 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Nov 3, 2020	M-217: Incorporation of the labeling revisions provided for in NDA 022253/S-039 and NDA 022255/S-022 into the lacosamide injection labeling

VIMPAT (SOLUTION) (ORAL) LACOSAMIDE
Drug Classes: 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 3, 2020

SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
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