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Aspirin; omeprazole - Generic Drug Details
What are the generic sources for aspirin; omeprazole and what is the scope of aspirin; omeprazole 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-five patent family members in twenty-three countries.
There are twenty-two drug master file entries for aspirin; omeprazole. One supplier is listed for this compound.
Summary for aspirin; omeprazole
| International Patents: | 45 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 14 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aspirin; omeprazole |
| DailyMed Link: | aspirin; omeprazole at DailyMed |
Pharmacology for aspirin; omeprazole
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor Proton Pump Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production Decreased Platelet Aggregation |
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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | RX | Yes | No | ➤ 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 |
International Patents for aspirin; omeprazole
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2012502015 | ➤ Sign Up |
| Norway | 20035275 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2010029335 | ➤ Sign Up |
| European Patent Office | 2797600 | ➤ Sign Up |
| Canada | 2449098 | ➤ Sign Up |
| China | 104519888 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for aspirin; omeprazole
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 5 | Finland | ➤ Sign Up | |
| 90013-1 | Sweden | ➤ Sign Up | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
| 1411900/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011 |
| 858 | Luxembourg | ➤ Sign Up | 91858, EXPIRES: 20251105 |
| C/GB11/015 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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