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Aspirin; omeprazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for aspirin; omeprazole?

Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Aralez Pharms and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty patent family members in twenty-two countries.

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

Summary for Generic Name: aspirin; omeprazole

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list21
Suppliers / Packagers: see list1
Clinical Trials: see list555
Drug Prices:see low prices
DailyMed Link:aspirin; omeprazole at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-002Sep 14, 2016RXYesYes9,364,439► SubscribeY ► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-001Sep 14, 2016RXYesNo6,926,907► SubscribeY ► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-002Sep 14, 2016RXYesYes9,539,214► Subscribe ► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-002Sep 14, 2016RXYesYes► Subscribe► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-001Sep 14, 2016RXYesNo9,539,214► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,345,695Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,865,190Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,161,920Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,198,888Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,220,698Method for delivering a pharmaceutical composition to patient in need thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aspirin; omeprazole

Country Document Number Estimated Expiration
Tunisia2011000096► Subscribe
Eurasian Patent Organization201491285► Subscribe
European Patent Office1411900► Subscribe
World Intellectual Property Organization (WIPO)2010029335► Subscribe
Denmark1411900► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ASPIRIN; OMEPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
5Finland► Subscribe
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
2012 00036Denmark► Subscribe
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
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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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