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.
Two suppliers are listed for this compound.
Summary for aspirin; omeprazole
International Patents: | 46 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 14 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aspirin; omeprazole |
DailyMed Link: | aspirin; omeprazole at DailyMed |
Recent Clinical Trials for aspirin; omeprazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Federal University of São Paulo | Phase 4 |
Yaling Han | Phase 4 |
Pharmacology for aspirin; omeprazole
Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor Proton Pump Inhibitor |
Mechanism of Action | Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Physiological Effect | Decreased Platelet Aggregation Decreased Prostaglandin Production |
Anatomical Therapeutic Chemical (ATC) Classes for aspirin; omeprazole
Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
YOSPRALA | Delayed-release Tablets | aspirin; omeprazole | 81 mg/40 mg and 325 mg/40 mg | 205103 | 1 | 2016-10-14 |
US Patents and Regulatory Information for aspirin; omeprazole
Expired US Patents for aspirin; omeprazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | See Plans and Pricing | See Plans and Pricing |
Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aspirin; omeprazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2004536809 | See Plans and Pricing | |
European Patent Office | 1411900 | COMPOSITIONS PHARMACEUTIQUES DESTINEES A LA LIBERATION COORDONNEE D'AINS (PHARMACEUTICAL COMPOSITIONS FOR THE COORDINATED DELIVERY OF NSAIDs) | See Plans and Pricing |
European Patent Office | 2260837 | Compositions pharmaceutiques pour l'administration coordonnée d'AINS (Pharmaceutical compositions for the coordinated delivery of NSAIDs) | See Plans and Pricing |
Norway | 2013014 | See Plans and Pricing | |
Japan | 4756823 | See Plans and Pricing | |
Cyprus | 1110842 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aspirin; omeprazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1411900 | 2011/016 | Ireland | See Plans and Pricing | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
1411900 | 91858 | Luxembourg | See Plans and Pricing | 91858, EXPIRES: 20251105 |
1411900 | 2011C/016 | Belgium | See Plans and Pricing | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | 1190013-1 | Sweden | See Plans and Pricing | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
1411900 | C01411900/01 | Switzerland | See Plans and Pricing | FORMER OWNER: POZEN, INC., US |
1411900 | SPC/GB11/015 | United Kingdom | See Plans and Pricing | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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