➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Boehringer Ingelheim
Moodys
Mallinckrodt
Merck

Last Updated: August 6, 2020

DrugPatentWatch Database Preview

YOSPRALA Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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.

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

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

US ANDA Litigation and Generic Entry Outlook for Yosprala

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2022. This may change due to patent challenges or generic licensing.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for YOSPRALA
Drug Prices for YOSPRALA

See drug prices for YOSPRALA

Generic Entry Opportunity Date for YOSPRALA
Generic Entry Date for YOSPRALA*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for YOSPRALA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
POZENPhase 3

See all YOSPRALA clinical trials

Paragraph IV (Patent) Challenges for YOSPRALA
Tradename Dosage Ingredient NDA Submissiondate
YOSPRALA TABLET, DELAYED RELEASE;ORAL aspirin; omeprazole 205103 2016-10-14

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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for YOSPRALA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011C/016 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900 18/2011 Austria   Start Trial PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900 91858 Luxembourg   Start Trial 91858, EXPIRES: 20251105
1411900 435 Finland   Start Trial
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Dow
Baxter
Johnson and Johnson
Harvard Business School

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 verification 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.