Details for New Drug Application (NDA): 217686
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NDA 217686 describes TRYVIO, which is a drug marketed by Idorsia and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the TRYVIO profile page.
The generic ingredient in TRYVIO is aprocitentan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aprocitentan profile page.
The generic ingredient in TRYVIO is aprocitentan. There is one drug master file entry for this compound. 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: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217686
Generic Entry Date for 217686*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 217686
| Mechanism of Action | Endothelin Receptor Antagonists |
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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