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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 Aralez Pharms 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-five patent family members in twenty-three countries.

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

Summary for aspirin; omeprazole

International Patents:	45
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

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

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Non-Orange Book US Patents for aspirin; omeprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,557,285	Pharmaceutical compositions for the coordinated delivery of NSAIDs
8,852,636	Pharmaceutical compositions for the coordinated delivery of NSAIDs
8,858,996	Pharmaceutical compositions for the coordinated delivery of NSAIDS
8,865,190	Pharmaceutical compositions for the coordinated delivery of NSAIDs

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International Patents for aspirin; omeprazole

Country	Document Number	Estimated Expiration
Australia	2006235929
Ukraine	115139
European Patent Office	1411900
Eurasian Patent Organization	201100313

Supplementary Protection Certificates for aspirin; omeprazole

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012 00036	Denmark
C/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900/01	Switzerland		PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105