Pharsight

1. Admelog Solostar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI-AVENTIS US	Pen-type injector	Mar, 2024 (25 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 11, 2020

Drugs and Companies using INSULIN LISPRO ingredient

Market Authorisation Date: 11 December, 2017

Treatment: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Dosage: SOLUTION;INTRAVENOUS, SUBCUTANEOUS

Strength	Dosage	Availability
300 UNITS/3ML (100 UNITS/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Prescription

ADMELOG SOLOSTAR family patents

2. Aldara patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7696159	BAUSCH	Treatment for basal cell carcinoma	Apr, 2024 (19 days ago)

Drugs and Companies using IMIQUIMOD ingredient

Market Authorisation Date: 27 February, 1997

Treatment: Works through the induction of interferon and other cytokines

Dosage: CREAM;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.05	17 Oct, 2006	1	25 Feb, 2010	24 Aug, 2010	Eligible

Strength	Dosage	Availability
5%	CREAM;TOPICAL	Discontinued

ALDARA family patents

3. Apidra Solostar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI AVENTIS US	Pen-type injector	Mar, 2024 (25 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Oct 24, 2011

Drugs and Companies using INSULIN GLULISINE RECOMBINANT ingredient

Market Authorisation Date: 16 April, 2004

Treatment: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Dosage: INJECTABLE;SUBCUTANEOUS

Strength	Dosage	Availability
300 UNITS/3ML	INJECTABLE;SUBCUTANEOUS	Prescription

APIDRA SOLOSTAR family patents

4. Arikayce Kit patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11159754A	2016-02-22	Generics [UK] Limited	Revoked
EP06787716A	2014-06-04	Generics [UK] Limited	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).
US9827317	INSMED INC	Sustained release of antiinfectives	Apr, 2024 (12 days ago)
US8802137	INSMED INC	Sustained release of antiinfectives	Apr, 2024 (12 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-214)	Sep 28, 2025
Generating Antibiotic Incentives Now(GAIN)	Sep 28, 2030

Drugs and Companies using AMIKACIN SULFATE ingredient

Market Authorisation Date: 28 September, 2018

Treatment: Treating mycobacterium avium complex (mac) lung disease in adults as part of a combination antibacterial drug regimen; Treating mycobacterium avium complex (mac) lung disease in adults as part of a co...

Dosage: SUSPENSION, LIPOSOMAL;INHALATION

Strength	Dosage	Availability
EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL;INHALATION	Prescription

ARIKAYCE KIT family patents

5. Bosulif patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE42376	PF PRISM CV	Substituted 3-cyanoquinolines	Apr, 2024 (7 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-163)	Dec 19, 2024
Orphan Drug Exclusivity(ODE-444)	Sep 26, 2030
New Indication(I-923)	Sep 26, 2026
Pediatric Exclusivity(PED)	Mar 26, 2027
New Indication(I-759)	Dec 19, 2020
Orphan Drug Exclusivity(ODE)	Sep 04, 2019
Orphan Drug Exclusivity(ODE-30)	Sep 04, 2019
New Chemical Entity Exclusivity(NCE)	Sep 04, 2017

Drugs and Companies using BOSUTINIB MONOHYDRATE ingredient

NCE-1 date: 26 March, 2026

Market Authorisation Date: 04 September, 2012

Treatment: NA

Dosage: TABLET;ORAL; CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 500 mg	06 Sep, 2016	2		23 Nov, 2026
400 mg	25 Oct, 2018	1		23 Nov, 2026

Strength	Dosage	Availability
EQ 400MG BASE	TABLET;ORAL	Prescription
EQ 50MG BASE	CAPSULE;ORAL	Prescription
EQ 100MG BASE	CAPSULE;ORAL	Prescription
EQ 500MG BASE	TABLET;ORAL	Prescription

BOSULIF family patents

6. Bydureon patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11180259A	2015-11-25	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP11180259A	2015-11-16	PHARMATHEN S.A.	Opposition rejected

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).
US7563871	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)
US9238076	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Jan 22, 2025
New Patient Population(NPP)	Jul 22, 2024
M(M-240)	Feb 15, 2022
M(M-162)	Sep 24, 2018
M(M-212)	Oct 20, 2020
M(M-224)	Apr 02, 2021
New Product(NP)	Jan 27, 2015

Drugs and Companies using EXENATIDE SYNTHETIC ingredient

Market Authorisation Date: 27 January, 2012

Treatment: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiab...

Dosage: FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

Strength	Dosage	Availability
2MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Discontinued

BYDUREON family patents

7. Bydureon Bcise patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11180259A	2015-11-25	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP11180259A	2015-11-16	PHARMATHEN S.A.	Opposition rejected

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).
US9238076	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)
US7563871	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Jul 22, 2024
Pediatric Exclusivity(PED)	Jan 22, 2025
M(M-240)	Feb 15, 2022
New Product(NP)	Oct 20, 2020

Drugs and Companies using EXENATIDE SYNTHETIC ingredient

Market Authorisation Date: 20 October, 2017

Dosage: SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

Strength	Dosage	Availability
2MG/0.85ML (2MG/0.85ML)	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Prescription

BYDUREON BCISE family patents

8. Bydureon Pen patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11180259A	2015-11-25	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP11180259A	2015-11-16	PHARMATHEN S.A.	Opposition rejected

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).
US7563871	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)
US9238076	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Jan 22, 2025
New Patient Population(NPP)	Jul 22, 2024
M(M-240)	Feb 15, 2022
M(M-162)	Sep 24, 2018
M(M-212)	Oct 20, 2020
M(M-224)	Apr 02, 2021
New Product(NP)	Jan 27, 2015

Drugs and Companies using EXENATIDE SYNTHETIC ingredient

Market Authorisation Date: 27 January, 2012

Treatment: Improving glycemic control in patients 10 years of age and older with type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise

Dosage: FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

Strength	Dosage	Availability
2MG	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	Discontinued

BYDUREON PEN family patents

9. Dexilant 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).
US8784885 (Pediatric)	TAKEDA PHARMS USA	Controlled release preparation	Apr, 2024 (5 days ago)
US8722084 (Pediatric)	TAKEDA PHARMS USA	Controlled release preparation	Apr, 2024 (5 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jan 30, 2012
New Patient Population(NPP)	Jul 08, 2019
Pediatric Exclusivity(PED)	Jul 30, 2012

Drugs and Companies using DEXLANSOPRAZOLE ingredient

Market Authorisation Date: 30 January, 2009

Treatment: NA

Dosage: CAPSULE, DELAYED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
30 mg	30 Nov, 2010	1		02 Aug, 2026	Extinguished

Strength	Dosage	Availability
30MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription
60MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription

DEXILANT family patents

10. Dexilant Solutab patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8784885 (Pediatric)	TAKEDA PHARMS USA	Controlled release preparation	Apr, 2024 (5 days ago)

Drugs and Companies using DEXLANSOPRAZOLE ingredient

Market Authorisation Date: 26 January, 2016

Treatment: NA

Dosage: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

Strength	Dosage	Availability
30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Discontinued

DEXILANT SOLUTAB family patents

11. Dutrebis patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169780 (Pediatric)	MERCK SHARP DOHME	N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase	Apr, 2024 (17 days ago)

Drugs and Companies using LAMIVUDINE; RALTEGRAVIR POTASSIUM ingredient

Market Authorisation Date: 06 February, 2015

Treatment: NA

Dosage: TABLET;ORAL

Strength	Dosage	Availability
150MG;EQ 300MG BASE	TABLET;ORAL	Discontinued

DUTREBIS family patents

12. Evekeo Odt patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10130580	AZURITY	Taste-masked pharmaceutical compositions	Apr, 2024 (a day ago)

Drugs and Companies using AMPHETAMINE SULFATE ingredient

Market Authorisation Date: 16 April, 2021

Treatment: NA

Dosage: TABLET, ORALLY DISINTEGRATING;ORAL

Strength	Dosage	Availability
20MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription
2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
15MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription
10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription
5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription

EVEKEO ODT family patents

13. Exservan patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11157819A	2014-06-11	Ahrens, Gabriele	Patent maintained as amended
EP02782151A	2013-06-12	Acino Pharma AG	Revoked
EP02782151A	2013-06-11	Germann, Sandra	Revoked
EP02801042A	2012-09-14	Ahrens, Gabriele	Patent maintained as amended
EP02801042A	2012-09-11	LTS LOHMANN Therapie-Systeme AG	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy’s Laboratories, Inc.
US8603514	June, 2017	Terminated-Denied	MonoSol Rx, LLC	Par Pharmaceutical, Inc.
US8603514	November, 2016	Terminated-Adverse Judgment	MonoSol Rx, LLC	Mylan Technologies, Inc.
US8603514	May, 2016	Terminated-Denied	MonoSol Rx, LLC	Dr. Reddy's Laboratories, Inc.
US8603514	December, 2015	Terminated-Denied	MONOSOL RX LLC	Teva Pharmaceuticals USA Inc

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8603514	AQUESTIVE	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Apr, 2024 (17 days ago)

Drugs and Companies using RILUZOLE ingredient

Market Authorisation Date: 22 November, 2019

Treatment: NA

Dosage: FILM;ORAL

Strength	Dosage	Availability
50MG	FILM;ORAL	Prescription

EXSERVAN family patents

14. Farxiga patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11180259A	2015-11-25	Teva Pharmaceutical Industries Ltd.	Opposition rejected
EP11180259A	2015-11-16	PHARMATHEN S.A.	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9238076	ASTRAZENECA AB	Polymer-based sustained release device	Apr, 2024 (5 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-857)	Apr 30, 2024
M(M-298)	May 08, 2026
M(M-238)	Feb 22, 2022
New Indication(I-834)	May 05, 2023
M(M-212)	Oct 20, 2020
New Chemical Entity Exclusivity(NCE)	Jan 08, 2019
M(M-157)	Mar 11, 2018
New Indication(I-841)	Oct 18, 2022

Drugs and Companies using DAPAGLIFLOZIN ingredient

NCE-1 date: 08 January, 2018

Market Authorisation Date: 08 January, 2014

Treatment: Treatment of type 2 diabetes mellitus in combination with exenatide

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	08 Jan, 2018	20	22 Feb, 2022	26 May, 2030	Deferred

Strength	Dosage	Availability
5MG	TABLET;ORAL	Prescription
10MG	TABLET;ORAL	Prescription

FARXIGA family patents

15. Gonal-f Rff Redi-ject patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7741268	EMD SERONO	Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant	Apr, 2024 (18 days ago)

Drugs and Companies using FOLLITROPIN ALFA/BETA ingredient

Market Authorisation Date: 25 November, 2019

Treatment: NA

Dosage: INJECTABLE;SUBCUTANEOUS

Strength	Dosage	Availability
450 IU/0.75ML	INJECTABLE;SUBCUTANEOUS	Prescription
300 IU/0.5ML	INJECTABLE;SUBCUTANEOUS	Prescription
900 IU/1.5ML	INJECTABLE;SUBCUTANEOUS	Prescription

GONAL-F RFF REDI-JECT family patents

16. Ionsys patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6975902	THE MEDICINES CO	Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof	Apr, 2024 (19 days ago)

Drugs and Companies using FENTANYL HYDROCHLORIDE ingredient

Market Authorisation Date: 22 May, 2006

Treatment: NA

Dosage: SYSTEM;IONTOPHORESIS, TRANSDERMAL

IONSYS family patents

17. Isentress patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169780 (Pediatric)	MSD SUB MERCK	N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase	Apr, 2024 (17 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Nov 22, 2020
New Dosage Form(NDF)	Dec 20, 2016
Pediatric Exclusivity(PED)	May 22, 2021

Drugs and Companies using RALTEGRAVIR POTASSIUM ingredient

Market Authorisation Date: 20 December, 2013

Treatment: NA

Dosage: POWDER;ORAL; TABLET, CHEWABLE;ORAL; TABLET;ORAL

ISENTRESS family patents

18. Isentress Hd patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169780 (Pediatric)	MSD SUB MERCK	N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase	Apr, 2024 (17 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Strength(NS)	May 26, 2020
New Dosing Schedule(D-167)	May 26, 2020
New Patient Population(NPP)	Dec 21, 2014
Pediatric Exclusivity(PED)	May 22, 2021
M(M-114)	Mar 28, 2015
New Chemical Entity Exclusivity(NCE)	Oct 12, 2012

Drugs and Companies using RALTEGRAVIR POTASSIUM ingredient

NCE-1 date: 22 May, 2020

Market Authorisation Date: 12 October, 2007

Treatment: NA

Dosage: TABLET;ORAL

ISENTRESS HD family patents

19. Kynmobi patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8603514	SUMITOMO PHARMA AM	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Apr, 2024 (17 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 21, 2023

Drugs and Companies using APOMORPHINE HYDROCHLORIDE ingredient

Market Authorisation Date: 21 May, 2020

Treatment: NA

Dosage: FILM;SUBLINGUAL

KYNMOBI family patents

20. Lantus Solostar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI AVENTIS US	Pen-type injector	Mar, 2024 (25 days ago)

Drugs and Companies using INSULIN GLARGINE RECOMBINANT ingredient

Market Authorisation Date: 27 April, 2007

Treatment: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Dosage: INJECTABLE;INJECTION

LANTUS SOLOSTAR family patents

21. Mavenclad 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).
US7888328	EMD SERONO INC	Oral formulations of cladribine	Apr, 2024 (9 days ago)
US8785415	EMD SERONO INC	Oral formulations of cladribine	Apr, 2024 (9 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 29, 2022

Drugs and Companies using CLADRIBINE ingredient

Market Authorisation Date: 29 March, 2019

Treatment: Treatment of ms with a tablet with an admixture of (a) an amorphous inclusion complex of cladribine and hydroxypropyl-b-cyclodextrin and (b) amorphous free cladribine and cyclodextrin as a non-inclusi...

Dosage: TABLET;ORAL

MAVENCLAD family patents

22. Ofev patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7989474	BOEHRINGER INGELHEIM	Use of Lck inhibitors for treatment of immunologic diseases	Apr, 2024 (14 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-261)	Sep 06, 2026
Pediatric Exclusivity(PED)	Mar 06, 2027
New Indication(I-805)	Sep 06, 2022
Orphan Drug Exclusivity(ODE)	Oct 15, 2021
New Chemical Entity Exclusivity(NCE)	Oct 15, 2019
New Indication(I-825)	Mar 09, 2023
Orphan Drug Exclusivity(ODE-77)	Oct 15, 2021

Drugs and Companies using NINTEDANIB ESYLATE ingredient

NCE-1 date: 06 March, 2026

Market Authorisation Date: 15 October, 2014

Treatment: Treatment of idiopathic pulmonary fibrosis (ipf)

Dosage: CAPSULE;ORAL

OFEV family patents

23. Oracea 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).
US8709478	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (13 days ago)
US8394406	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (13 days ago)
US8394405	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (13 days ago)
US8470364	GALDERMA LABS LP	Once daily formulations of tetracyclines	Apr, 2024 (13 days ago)

Drugs and Companies using DOXYCYCLINE ingredient

Market Authorisation Date: 26 May, 2006

Treatment: Treatment of only inflammatory lesions (papules and pustules) of rosacea

Dosage: CAPSULE;ORAL

ORACEA family patents

24. Relistor 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).
US8552025	SALIX PHARMS	Stable methylnaltrexone preparation	Apr, 2024 (12 days ago)
US9669096	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (12 days ago)
US10376584	SALIX PHARMS	Stable pharmaceutical formulations of methylnaltrexone	Apr, 2024 (12 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 24, 2013

Drugs and Companies using METHYLNALTREXONE BROMIDE ingredient

NCE-1 date: 24 April, 2012

Market Authorisation Date: 27 September, 2010

Treatment: Treatment of opioid-induced constipation

Dosage: SOLUTION;SUBCUTANEOUS

RELISTOR family patents

25. Soliqua 100/33 patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI-AVENTIS US	Pen-type injector	Mar, 2024 (25 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Combination(NC)	Nov 21, 2019
New Chemical Entity Exclusivity(NCE)	Jul 27, 2021

Drugs and Companies using INSULIN GLARGINE; LIXISENATIDE ingredient

NCE-1 date: 27 July, 2020

Market Authorisation Date: 21 November, 2016

Treatment: Improvement in glycemic control in adults with type 2 diabetes mellitus by use of a pen injector with a threaded drive sleeve

Dosage: SOLUTION;SUBCUTANEOUS

SOLIQUA 100/33 family patents

26. Suboxone patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8603514	INDIVIOR	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Apr, 2024 (17 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Aug 30, 2013

Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 30 August, 2010

Treatment: Treatment of opioid dependence/sublingual or buccal application

Dosage: FILM;BUCCAL, SUBLINGUAL

SUBOXONE family patents

27. Sympazan patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8603514	OTTER PHARMS	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions	Apr, 2024 (17 days ago)

Drugs and Companies using CLOBAZAM ingredient

Market Authorisation Date: 01 November, 2018

Treatment: NA

Dosage: FILM;ORAL

SYMPAZAN family patents

28. Tobi Podhaler patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE47526	MYLAN SPECIALITY LP	Aerosolization apparatus with air inlet shield	Apr, 2024 (11 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 22, 2016

Drugs and Companies using TOBRAMYCIN ingredient

Market Authorisation Date: 22 March, 2013

Treatment: NA

Dosage: POWDER;INHALATION

TOBI PODHALER family patents

29. Toujeo Max Solostar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI US SERVICES	Pen-type injector	Mar, 2024 (25 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Feb 25, 2018
New Patient Population(NPP)	Nov 26, 2022

Drugs and Companies using INSULIN GLARGINE RECOMBINANT ingredient

Market Authorisation Date: 25 February, 2015

Treatment: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Dosage: SOLUTION;SUBCUTANEOUS

TOUJEO MAX SOLOSTAR family patents

30. Toujeo Solostar patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9011391	SANOFI US SERVICES	Pen-type injector	Mar, 2024 (25 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Feb 25, 2018
New Patient Population(NPP)	Nov 26, 2022

Drugs and Companies using INSULIN GLARGINE RECOMBINANT ingredient

Market Authorisation Date: 25 February, 2015

Treatment: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Dosage: SOLUTION;SUBCUTANEOUS

TOUJEO SOLOSTAR family patents

31. Veltassa 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).
US8475780	VIFOR PHARMA	Ion binding polymers and uses thereof	Mar, 2024 (21 days ago)
US8778324	VIFOR PHARMA	Ion binding polymers and uses thereof	Mar, 2024 (21 days ago)
US8287847	VIFOR PHARMA	Ion binding polymers and uses thereof	Mar, 2024 (21 days ago)
US8889115	VIFOR PHARMA	Ion binding polymers and uses thereof	Mar, 2024 (21 days ago)
US10485821	VIFOR PHARMA	Ion binding polymers and uses thereof	Mar, 2024 (21 days ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Oct 02, 2026
New Strength(NS)	Oct 02, 2026
New Chemical Entity Exclusivity(NCE)	Oct 21, 2020

Drugs and Companies using PATIROMER SORBITEX CALCIUM ingredient

NCE-1 date: 22 October, 2019

Market Authorisation Date: 02 October, 2023

Treatment: Treatment of hyperkalemia

Dosage: POWDER;ORAL

VELTASSA family patents

32. Xhance patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8522778	OPTINOSE US INC	Nasal devices	Apr, 2024 (7 hours ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Sep 18, 2020

Drugs and Companies using FLUTICASONE PROPIONATE ingredient

Market Authorisation Date: 18 September, 2017

Treatment: NA

Dosage: SPRAY, METERED;NASAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
400 mg	12 Oct, 2011	1		11 Mar, 2029
600 mg	21 Oct, 2022	1		30 Mar, 2032

Strength	Dosage	Availability
EQ 100MG BASE/PACKET	POWDER;ORAL	Prescription
EQ 25MG BASE	TABLET, CHEWABLE;ORAL	Prescription
EQ 400MG BASE	TABLET;ORAL	Prescription
EQ 100MG BASE	TABLET, CHEWABLE;ORAL	Prescription

Strength	Dosage	Availability
25MG	FILM;SUBLINGUAL	Discontinued
15MG	FILM;SUBLINGUAL	Discontinued
10MG	FILM;SUBLINGUAL	Discontinued
30MG	FILM;SUBLINGUAL	Discontinued
20MG	FILM;SUBLINGUAL	Discontinued

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8394405	June, 2013	FWD Entered	Supernus Pharmaceuticals, Inc.	Amneal Pharamceuticals, LLC
US8394406	June, 2013	FWD Entered

Application	Filing Date	Opposition Party	Legal Status

EP10184575A	2015-09-30	Actavis Group PTC ehf	Revoked
EP10184575A	2015-09-29	Fresenius Kabi Deutschland GmbH	Revoked
EP04759349A	2015-09-24	Actavis Group PTC ehf	Patent maintained as amended
EP04759349A	2015-09-24	Fresenius Kabi Deutschland GmbH	Patent maintained as amended
EP10184684A	2015-09-24	Fresenius Kabi Deutschland GmbH	Revoked
EP10184684A	2015-09-24	Actavis Group PTC ehf	Revoked

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
12 mg/0.6 mL	22 Jul, 2015	1	31 Dec, 2030
8 mg/0.4 mL	08 Sep, 2015	1	31 Dec, 2030
150 mg	06 Sep, 2016	1	10 Mar, 2031

Strength	Dosage	Availability
12MG/0.6ML (12MG/0.6ML)	SOLUTION;SUBCUTANEOUS	Prescription
8MG/0.4ML (8MG/0.4ML)	SOLUTION;SUBCUTANEOUS	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mg/vial	26 Jan, 2009	2	24 Mar, 2009	31 Jul, 2018	Eligible
2 mg/0.5 mg* and 8 mg/2 mg	15 Oct, 2012	1		13 Feb, 2023	Extinguished
4 mg/1 mg	14 May, 2013	1		13 Feb, 2023	Extinguished
12 mg/3 mg	14 May, 2013	1		13 Feb, 2023	Extinguished

Strength	Dosage	Availability
EQ 2MG BASE;EQ 0.5MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 12MG BASE;EQ 3MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 4MG BASE;EQ 1MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription
EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL	Prescription

Strength	Dosage	Availability
EQ 16.8GM BASE/PACKET	POWDER;ORAL	Prescription
EQ 25.2GM BASE/PACKET	POWDER;ORAL	Prescription
EQ 8.4GM BASE/PACKET	POWDER;ORAL	Prescription
EQ 1GM BASE/PACKET	POWDER;ORAL	Prescription

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