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Last Updated: July 27, 2021

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Aspirin; omeprazole - Generic Drug Details

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What are the generic sources for aspirin; omeprazole and what is the scope of freedom to operate?

Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Genus Lifesciences and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aspirin; omeprazole has forty-six patent family members in twenty-three countries.

There are twenty-two drug master file entries for aspirin; omeprazole. Two suppliers are listed for this compound.

Recent Clinical Trials for aspirin; omeprazole

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Yaling HanPhase 4

See all aspirin; omeprazole clinical trials

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

US Patents and Regulatory Information for aspirin; omeprazole

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 205103-002 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 aspirin; omeprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011C/016 Belgium ⤷  Try it Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1411900 18/2011 Austria ⤷  Try it Free 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 132012902015795 Italy ⤷  Try it Free PRODUCT NAME: NAPROSSENE E ESOMEPRAZOLO SALE DI MAGNESIO TRIIDRATO(VIMOVO); AUTHORISATION NUMBER(S) AND DATE(S): PL 17901/0263-0001, 20101105;DA 40611016/M A 40611129/M, 20110808
1411900 435 Finland ⤷  Try it Free
1411900 CA 2012 00036 Denmark ⤷  Try it Free
1411900 C01411900/01 Switzerland ⤷  Try it Free PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Johnson and Johnson
AstraZeneca
Mallinckrodt
McKinsey

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