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Last Updated: December 11, 2019

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Aspirin; omeprazole - Generic Drug Details

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What are the generic drug sources for aspirin; omeprazole and what is the scope of patent protection?

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. Five 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:	5
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
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

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. ACTAVIS LABORATORIES FL., INC.	2015-05-13
HORIZON PHARMA, INC. v. LUPIN LTD.	2015-05-13

See all aspirin; omeprazole litigation

PTAB Litigation

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

See all aspirin; omeprazole litigation

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	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	205103-002	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	205103-001	Sep 14, 2016		RX	Yes	No	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				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	200301321	Start Trial
Japan	4756823	Start Trial
Eurasian Patent Organization	201491285	Start Trial
World Intellectual Property Organization (WIPO)	2010029335	Start Trial
Denmark	1411900	Start Trial
Mexico	2014007935	Start Trial
European Patent Office	2163241	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	C300481	Netherlands	Start Trial	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	2011C/016	Belgium	Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900	C01411900/01	Switzerland	Start Trial	PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
1411900	2011/016	Ireland	Start Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
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	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	SPC/GB11/015	United Kingdom	Start Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 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 verifification 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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