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Last Updated: October 20, 2020

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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.

Summary for aspirin; omeprazole
Recent Clinical Trials for aspirin; omeprazole

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of 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 205103-001 Sep 14, 2016 RX Yes No   Start Trial   Start Trial   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
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 205103-002 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
>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 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 91858 Luxembourg   Start Trial 91858, EXPIRES: 20251105
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 C01411900/01 Switzerland   Start Trial PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>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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