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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Cantor Fitzgerald
Deloitte
Mallinckrodt
QuintilesIMS
Julphar
Accenture
Cerilliant
Dow

Generated: July 23, 2017

DrugPatentWatch Database Preview

YOSPRALA Drug Profile

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What is the patent landscape for Yosprala, and when can generic versions of Yosprala launch?

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-one 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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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, 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, 2016RXYesNo9,364,439► 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
9,161,920Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,198,888Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,557,285Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,220,698Method for delivering a pharmaceutical composition to patient in need thereof► Subscribe
8,858,996Pharmaceutical 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
Japan2012502015► Subscribe
Norway2013014► Subscribe
Spain2348710► Subscribe
South Korea20110079641► Subscribe
Mexico2014007935► 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
1411900/01Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
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
2012 00036Denmark► Subscribe
858Luxembourg► Subscribe91858, EXPIRES: 20251105
90013-1Sweden► SubscribePRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Deloitte
Cerilliant
Julphar
McKesson
Express Scripts
Johnson and Johnson
Medtronic
Chubb

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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