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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 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. Two 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:	2
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

Identify potential brand extensions & 505(b)(2) entrants

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

See all aspirin; omeprazole clinical trials

Pharmacology for aspirin; omeprazole

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

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

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			Y
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No			Y
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No

International Patents for aspirin; omeprazole

Country	Patent Number	Estimated Expiration
South Africa	201102645
European Patent Office	1411900
Germany	60237087
China	104519888

Supplementary Protection Certificates for aspirin; omeprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	132012902015795	Italy		PRODUCT NAME: NAPROSSENE E ESOMEPRAZOLO SALE DI MAGNESIO TRIIDRATO(VIMOVO); AUTHORISATION NUMBER(S) AND DATE(S): PL 17901/0263-0001, 20101105;DA 40611016/M A 40611129/M, 20110808
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105