Aspirin; omeprazole - Generic Drug Details

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What are the generic sources for aspirin; omeprazole and what is the scope of freedom to operate?

Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Genus Lifesciences and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aspirin; omeprazole has forty-six patent family members in twenty-three countries.

There are twenty-two drug master file entries for aspirin; omeprazole. Three suppliers are listed for this compound.

Summary for aspirin; omeprazole

International Patents:	46
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	22
Suppliers / Packagers:	3
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin; omeprazole
DailyMed Link:	aspirin; omeprazole at DailyMed

Recent Clinical Trials for aspirin; omeprazole

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Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
Yaling Han	Phase 4

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Recent Litigation for aspirin; omeprazole

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District Court Litigation

Case Name	Date
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2017-01-23
HORIZON PHARMA, INC. v. DR. REDDY'S LABORATORIES INC.	2015-05-13
HORIZON PHARMA, INC. v. ACTAVIS LABORATORIES FL., INC.	2015-05-13

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PTAB Litigation

Petitioner	Date
Coalition for Affordable Drugs VII LLC	2015-05-21

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Pharmacology for aspirin; omeprazole

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Drug Class	Proton Pump Inhibitor Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE

Tradename	Dosage	Ingredient	NDA	Submissiondate
YOSPRALA	TABLET, DELAYED RELEASE;ORAL	aspirin; omeprazole	205103	2016-10-14

US Patents and Regulatory Information for aspirin; omeprazole

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for aspirin; omeprazole

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Country	Patent Number	Estimated Expiration
China	104519888	Start Trial
Japan	4756823	Start Trial
European Patent Office	2260837	Start Trial
Eurasian Patent Organization	201100313	Start Trial
Canada	2736547	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for aspirin; omeprazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria	Start Trial	PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900	2011C/016	Belgium	Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900	122012000052	Germany	Start Trial	PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	C300481	Netherlands	Start Trial	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	CA 2012 00036	Denmark	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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