Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Colorcon
UBS
US Department of Justice
Mallinckrodt
Novartis
Cantor Fitzgerald
Fuji
Farmers Insurance

Generated: February 23, 2018

DrugPatentWatch Database Preview

YOSPRALA Drug Profile

« Back to Dashboard

When do Yosprala patents expire, 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-five patent family members in twenty-three 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.

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
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aralez Pharms YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 RX Yes Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for YOSPRALA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Tablets 81 mg/40 mg ➤ Subscribe 10/14/2016

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
8,557,285 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
8,865,190 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,393,208 Method for delivering a pharmaceutical composition to patient in need thereof ➤ Sign Up
9,161,920 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,220,698 Method for delivering a pharmaceutical composition to patient in need thereof ➤ Sign Up
9,707,181 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,345,695 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,198,888 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
8,852,636 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
8,858,996 Pharmaceutical compositions for the coordinated delivery of NSAIDS ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for YOSPRALA

Supplementary Protection Certificates for YOSPRALA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
11/016 Ireland ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
90013-1 Sweden ➤ Sign Up PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
5 Finland ➤ Sign Up
00481 Netherlands ➤ Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
2012 00036 Denmark ➤ Sign Up
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
858 Luxembourg ➤ Sign Up 91858, EXPIRES: 20251105
1411900/01 Switzerland ➤ Sign Up PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKinsey
Fuji
Express Scripts
Chubb
Cerilliant
Farmers Insurance
Baxter
Dow

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.

botpot