Details for New Drug Application (NDA): 217686
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The generic ingredient in TRYVIO is aprocitentan. One supplier is listed for this compound. Additional details are available on the aprocitentan profile page.
Summary for 217686
Tradename: | TRYVIO |
Applicant: | Idorsia |
Ingredient: | aprocitentan |
Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217686
Generic Entry Date for 217686*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*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.
Suppliers and Packaging for NDA: 217686
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRYVIO | aprocitentan | TABLET;ORAL | 217686 | NDA | Idorsia Pharmaceuticals Ltd | 80491-8012 | 80491-8012-3 | 1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE |
TRYVIO | aprocitentan | TABLET;ORAL | 217686 | NDA | Idorsia Pharmaceuticals Ltd | 80491-8012 | 80491-8012-8 | 1 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Mar 19, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 22, 2029 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | 10,919,881 | Patent Expiration: | Feb 26, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | 11,174,247 | Patent Expiration: | Nov 6, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF HYPERTENSION IN COMBINATION WITH OTHER ANTIHYPERTENSIVE DRUGS, INCLUDING AN ANGIOTENSIN RECEPTOR BLOCKER, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER DRUGS |
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