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Generated: September 19, 2018

DrugPatentWatch Database Preview

YOSPRALA Drug Profile

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Which patents cover Yosprala, and when can generic versions of Yosprala launch?

Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

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.

Drug patent expirations by year for YOSPRALA
Generic Entry Opportunity Date for YOSPRALA
Generic Entry Date for YOSPRALA*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
NDA:
Dosage:
TABLET, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for YOSPRALA

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 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for YOSPRALA
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 81 mg/40 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for 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
9,801,824 Method for delivering a pharmaceutical composition to patient in need thereof ➤ Sign Up
8,557,285 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,161,920 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
8,865,190 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for YOSPRALA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
858 Luxembourg ➤ Sign Up 91858, EXPIRES: 20251105
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900/01 Switzerland ➤ Sign Up PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481 Netherlands ➤ Sign Up 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:

Federal Trade Commission
Queensland Health
Farmers Insurance
Chubb
Deloitte
Cerilliant
Citi
McKesson
QuintilesIMS

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