Pharsight

1. Duexis patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8309127	HORIZON	Stable compositions of famotidine and ibuprofen	Jul, 2026 (2 years from now)
US8501228	HORIZON	Stable compositions of famotidine and ibuprofen	Jul, 2026 (2 years from now)
US8067451	HORIZON	Methods and medicaments for administration of ibuprofen	Jul, 2026 (2 years from now)
US8318202	HORIZON	Stable compositions of famotidine and ibuprofen	Jul, 2026 (2 years from now)
US8449910	HORIZON	Stable compositions of famotidine and ibuprofen	Jul, 2026 (2 years from now)
US8067033	HORIZON	Stable compositions of famotidine and ibuprofen	Jul, 2026 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Combination(NC)	Apr 23, 2014

Drugs and Companies using FAMOTIDINE; IBUPROFEN ingredient

Market Authorisation Date: 23 April, 2011

Treatment: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
800 mg/26.6 mg	06 Dec, 2011	1		18 Jul, 2026	Extinguished

Strength	Dosage	Availability
26.6MG;800MG	TABLET;ORAL	Prescription

DUEXIS family patents

2. Pennsaid patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9339551	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9168304	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9220784	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9132110	HORIZON	Treatment of pain with topical diclofenac	Oct, 2027 (3 years from now)
US9168305	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9539335	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9339552	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8871809	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8563613	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9101591	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9066913	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8252838	HORIZON	Diclofenac topical formulation	Apr, 2028 (3 years from now)
US9415029	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8618164	HORIZON	Treatment of pain with topical diclofenac compounds	Jul, 2029 (5 years from now)
US9370501	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US9375412	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8217078	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8741956	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8546450	HORIZON	Treatment of pain with topical diclofenac compounds	Aug, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jan 16, 2017

Drugs and Companies using DICLOFENAC SODIUM ingredient

Market Authorisation Date: 16 January, 2014

Treatment: Use of topical diclofenac for treating pain; Use of topical diclofenac sodium for treating pain; Use of topical diclofenac on a joint for treating osteoarthritis; Use of topical diclofenac on the knee...

Dosage: SOLUTION;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.015	11 Jul, 2012	1	27 May, 2014	10 Jul, 2029	Eligible
0.02	03 Jun, 2014	1		09 Aug, 2030	Extinguished

Strength	Dosage	Availability
2%	SOLUTION;TOPICAL	Prescription

PENNSAID family patents

3. Procysbi patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP12169866A	2020-09-18	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9925157	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925156	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925158	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9198882	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9192590	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925156	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925158	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925157	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US8129433	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jan, 2027 (2 years from now)
US9925157 (Pediatric)	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jul, 2027 (3 years from now)
US9925156 (Pediatric)	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jul, 2027 (3 years from now)
US9925158 (Pediatric)	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jul, 2027 (3 years from now)
US9198882 (Pediatric)	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jul, 2027 (3 years from now)
US9192590 (Pediatric)	HORIZON	Enterically coated cysteamine, cystamine and derivatives thereof	Jul, 2027 (3 years from now)
US8026284	HORIZON	Enterically coated cystamine, cysteamine and derivatives thereof	Sep, 2027 (3 years from now)
US8026284 (Pediatric)	HORIZON	Enterically coated cystamine, cysteamine and derivatives thereof	Mar, 2028 (3 years from now)
US9233077	HORIZON	Delayed release cysteamine bead formulation, and methods of making and using same	Jun, 2034 (10 years from now)
US9173851	HORIZON	Delayed release cysteamine bead formulation, and methods of making and using same	Jun, 2034 (10 years from now)
US9233077 (Pediatric)	HORIZON	Delayed release cysteamine bead formulation, and methods of making and using same	Dec, 2034 (10 years from now)
US9173851 (Pediatric)	HORIZON	Delayed release cysteamine bead formulation, and methods of making and using same	Dec, 2034 (10 years from now)
US10328037	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Aug, 2036 (12 years from now)
US10905662	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Aug, 2036 (12 years from now)
US10548859	HORIZON	Methods for storing Cysteamine formulations and related methods of treatment	Aug, 2036 (12 years from now)
US10143665	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Aug, 2036 (12 years from now)
US10328037 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10905662 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10548859 (Pediatric)	HORIZON	Methods for storing Cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10143665 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-162)	Dec 22, 2024
Pediatric Exclusivity(PED)	Jun 22, 2025
Orphan Drug Exclusivity(ODE)	Aug 14, 2022
New Patient Population(NPP)	Aug 14, 2018
M(M-216)	Dec 22, 2020
Orphan Drug Exclusivity(ODE-45)	Apr 30, 2020
Orphan Drug Exclusivity(ODE-97)	Aug 14, 2022
New Dosage Form(NDF)	Apr 30, 2016

Drugs and Companies using CYSTEAMINE BITARTRATE ingredient

Market Authorisation Date: 30 April, 2013

Treatment: Management of nephropathic cystinosis by administering a total daily dose in two divided doses

Dosage: CAPSULE, DELAYED RELEASE;ORAL; GRANULE, DELAYED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg and 75 mg	11 May, 2020	1		16 Aug, 2036
75 mg/Packet and 300 mg/Packet	16 Dec, 2021	1		16 Aug, 2036

Strength	Dosage	Availability
EQ 25MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Prescription
EQ 75MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Prescription
EQ 300MG BASE/PACKET	GRANULE, DELAYED RELEASE;ORAL	Prescription
EQ 75MG BASE/PACKET	GRANULE, DELAYED RELEASE;ORAL	Prescription

PROCYSBI family patents

4. Rayos patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP07801510A	2013-07-31	Laboratorios Liconsa, S.A.	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6488960	HORIZON	Corticosteroid formulation	Mar, 2020 (4 years ago)
US6677326	HORIZON	Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration	Mar, 2020 (4 years ago)
US8309124	HORIZON	Delayed release tablet with defined core geometry	Apr, 2024 (4 days ago)
US9186332	HORIZON	Delayed release tablet with defined core geometry	Apr, 2024 (4 days ago)
US9040085	HORIZON	Delayed release tablet with defined core geometry	Apr, 2024 (4 days ago)
US8394407	HORIZON	Delayed release tablet with defined core geometry	Apr, 2024 (4 days ago)
US9504699	HORIZON	Delayed-release glucocorticoid treatment of rheumatoid disease	Aug, 2027 (3 years from now)
US8168218	HORIZON	Delayed release tablet with defined core geometry	Jan, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-128)	Jul 26, 2015

Drugs and Companies using PREDNISONE ingredient

Market Authorisation Date: 26 July, 2012

Treatment: Treatment of rheumatoid arthritis by delayed release formulation of 1mg or 2mg of prednisone; Treatment of pulmonary, gastrointestinal and/or rheumatological diseases or conditions by use of delayed r...

Dosage: TABLET, DELAYED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1 mg, 2 mg, and 5 mg	26 Nov, 2012	1	25 Apr, 2017		Deferred

Strength	Dosage	Availability
1MG	TABLET, DELAYED RELEASE;ORAL	Prescription
2MG	TABLET, DELAYED RELEASE;ORAL	Prescription
5MG	TABLET, DELAYED RELEASE;ORAL	Prescription

RAYOS family patents

5. Vimovo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP02734602A	2011-04-21	CHATFIELD PHARMACEUTICALS LIMITED	Patent maintained as amended
EP02734602A	2011-04-15	STRAWMAN LIMITED	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9393208	July, 2018	Terminated-Other	Pozen Inc.	Dr. Reddy's Lab., Inc.
US9220698	April, 2018	FWD Entered	Horizon Pharma USA, Inc.	Dr. Reddy's Laboratories, Inc.
US9393208	December, 2017	FWD Entered	Horizon Pharma USA, Inc.	Mylan Pharmaceuticals Inc.
US9220698	August, 2017	Terminated-Other	Horizon Pharma USA, Inc.	Mylan Pharmaceuticals Inc.
US8858996	August, 2015	FWD Entered	Pozen Inc.	Lupin Pharmaceuticals Inc.
US8852636	August, 2015	Terminated-Denied	Pozen Inc.	Lupin Pharmaceuticals Inc
US8945621	August, 2015	FWD Entered	Pozen Inc	Coalition for Affordable Drugs VII LLC
US8852636	August, 2015	Terminated-Denied	Pozen Inc.	Coalition for Affordable Drugs VII LLC
US8858996	June, 2015	Terminated-Denied	Pozen Inc.	Coalition for Affordable Drugs VII LLC
US6926907	May, 2015	Terminated-Denied	POZEN Inc.	Coalition for Affordable Drugs VII LLC

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6875872	HORIZON	Compounds	May, 2014 (9 years ago)
US5900424	HORIZON	Omeprazole magnesium salt form	May, 2016 (7 years ago)
US7411070	HORIZON	Form of S-omeprazole	May, 2018 (5 years ago)
US6369085	HORIZON	Form of S-omeprazole	May, 2018 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6875872 (Pediatric)	HORIZON	Compounds	Nov, 2014 (9 years ago)
US5714504	HORIZON	Compositions	Feb, 2015 (9 years ago)
US5714504 (Pediatric)	HORIZON	Compositions	Aug, 2015 (8 years ago)
US5900424 (Pediatric)	HORIZON	Omeprazole magnesium salt form	Nov, 2016 (7 years ago)
US7745466	HORIZON	Form of S-omeprazole	Oct, 2018 (5 years ago)
US7411070 (Pediatric)	HORIZON	Form of S-omeprazole	Nov, 2018 (5 years ago)
US6369085 (Pediatric)	HORIZON	Form of S-omeprazole	Nov, 2018 (5 years ago)
US9161920	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US9345695	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US8858996	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDS	May, 2022 (1 year, 10 months ago)
US8852636	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US8557285	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US9198888	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US9707181	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	May, 2022 (1 year, 10 months ago)
US6926907	HORIZON	Pharmaceutical compositions for the coordinated delivery of NSAIDs	Feb, 2023 (1 year, 1 month ago)
US9393208	HORIZON	Method for delivering a pharmaceutical composition to patient in need thereof	Sep, 2029 (5 years from now)
US9220698	HORIZON	Method for delivering a pharmaceutical composition to patient in need thereof	Mar, 2031 (6 years from now)
US8945621	HORIZON	Method for treating a patient at risk for developing an NSAID-associated ulcer	Oct, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Jul 06, 2020
New Combination(NC)	Apr 30, 2013

Drugs and Companies using ESOMEPRAZOLE MAGNESIUM; NAPROXEN ingredient

Market Authorisation Date: 30 April, 2010

Treatment: Risk-reduction of nsaid-associated gastric ulcer; Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment; Relief of signs and symptoms of arthritis and risk-reduction of n...