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Aspirin; omeprazoleis 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
|Federal University of São Paulo||Phase 4|
|Fundação de Amparo à Pesquisa do Estado de São Paulo||Phase 4|
|Yaling Han||Phase 4|
Pharmacology 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||Start Trial||Start Trial||Y||Start Trial|
|Genus Lifesciences||YOSPRALA||aspirin; omeprazole||TABLET, DELAYED RELEASE;ORAL||205103-002||Sep 14, 2016||DISCN||Yes||No||Start Trial||Start Trial||Start Trial|
|Genus Lifesciences||YOSPRALA||aspirin; omeprazole||TABLET, DELAYED RELEASE;ORAL||205103-001||Sep 14, 2016||DISCN||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Genus Lifesciences||YOSPRALA||aspirin; omeprazole||TABLET, DELAYED RELEASE;ORAL||205103-001||Sep 14, 2016||DISCN||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|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1411900||SPC/GB11/015||United Kingdom||Start Trial||PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105|
|1411900||122012000052||Germany||Start Trial||PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105|
|1411900||132012902015795||Italy||Start Trial||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||2011/016||Ireland||Start Trial||PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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