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YOSPRALA Drug Profile

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Which patents cover Yosprala, and what substitute generic drugs are available?

Yosprala is a drug marketed by Aralez Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; omeprazole profile page.

Summary for Tradename: YOSPRALA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:YOSPRALA 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;ORAL205103-001Sep 14, 2016RXYesNo6,926,907► SubscribeY ► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-002Sep 14, 2016RXYesYes6,926,907► SubscribeY ► Subscribe
Aralez Pharms
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL205103-001Sep 14, 2016RXYesNo9,539,214► Subscribe ► Subscribe
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, 2016RXYesNo8,206,741► SubscribeY ► Subscribe
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Paragraph IV activity for: YOSPRALA

Drugname Dosage Strength RLD Submissiondate
aspirin and omeprazoleDelayed-release Tablets 81 mg/40 mgYosprala10/14/2016

Non-Orange Book Patents for Tradename: YOSPRALA

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
8,557,285Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,198,888Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,393,208Method for delivering a pharmaceutical composition to patient in need thereof► Subscribe
9,345,695Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,852,636Pharmaceutical compositions for the coordinated delivery of NSAIDs► 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 Tradename: YOSPRALA

Country Document Number Estimated Expiration
China102209529► Subscribe
Japan2012502015► Subscribe
Eurasian Patent Organization006398► Subscribe
China104519888► Subscribe
European Patent Office2344139► 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: YOSPRALA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
5Finland► Subscribe
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2012 00036Denmark► Subscribe
858Luxembourg► Subscribe91858, EXPIRES: 20251105
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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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