Details for New Drug Application (NDA): 205103
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NDA 205103 describes YOSPRALA, which is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YOSPRALA profile page.
The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.
The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; omeprazole profile page.
Summary for 205103
| Tradename: | YOSPRALA |
| Applicant: | Genus Lifesciences |
| Ingredient: | aspirin; omeprazole |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205103
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 81MG;40MG | ||||
| Approval Date: | Sep 14, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 2, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 325MG;40MG | ||||
| Approval Date: | Sep 14, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 13, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS | ||||||||
Expired US Patents for NDA 205103
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Genus Lifesciences | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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