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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
Citi
Mallinckrodt
Chinese Patent Office
Healthtrust
Baxter
AstraZeneca
Boehringer Ingelheim

Generated: July 20, 2018

DrugPatentWatch Database Preview

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

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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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 ➤ Try a Free Trial
8,852,636 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Try a Free Trial
8,858,996 Pharmaceutical compositions for the coordinated delivery of NSAIDS ➤ Try a Free Trial
8,865,190 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for aspirin; omeprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00036 Denmark ➤ Try a Free Trial
C/GB11/015 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481 Netherlands ➤ Try a Free Trial 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

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Daiichi Sankyo
US Army
Cipla
Johnson and Johnson
Fish and Richardson
Boehringer Ingelheim
Accenture

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.