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Last Updated: October 20, 2020

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

See all aspirin; omeprazole clinical trials

Pharmacology for aspirin; omeprazole

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

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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	205103-001	Sep 14, 2016		RX	Yes	No	Start Trial	Start Trial				Start Trial
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		RX	Yes	No	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	205103-002	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
Eurasian Patent Organization	028049	Start Trial
Portugal	1411900	Start Trial
Australia	2002305758	Start Trial
Denmark	1411900	Start Trial
Mexico	2011002515	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	1190013-1	Sweden	Start Trial	PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900	91858	Luxembourg	Start Trial	91858, EXPIRES: 20251105
1411900	SPC/GB11/015	United Kingdom	Start Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	C01411900/01	Switzerland	Start Trial	PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
1411900	C300481	Netherlands	Start Trial	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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