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Aspirin; omeprazole - Generic Drug Details

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What are the generic sources for aspirin; omeprazole and what is the scope of aspirin; omeprazole 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.

There are twenty-one drug master file entries for aspirin; omeprazole. One supplier is listed for this compound.

Summary for aspirin; omeprazole

US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	21
Suppliers / Packagers:	1
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin; omeprazole
DailyMed Link:	aspirin; omeprazole at DailyMed

Pharmacology for aspirin; omeprazole

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

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

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International Patents for aspirin; omeprazole

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Country	Document Number	Estimated Expiration
South Korea	20110079641	➤ Sign Up
Morocco	32692	➤ Sign Up
Australia	2002305758	➤ Sign Up
Eurasian Patent Organization	201100313	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for aspirin; omeprazole

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
858	Luxembourg	➤ Sign Up	91858, EXPIRES: 20251105
C/GB11/015	United Kingdom	➤ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900/01	Switzerland	➤ Sign Up	PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481	Netherlands	➤ Sign Up	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description