Details for New Drug Application (NDA): 218490
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NDA 218490 describes OPSYNVI, which is a drug marketed by Actelion and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OPSYNVI profile page.
The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan; tadalafil profile page.
The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan; tadalafil profile page.
Summary for 218490
| Tradename: | OPSYNVI |
| Applicant: | Actelion |
| Ingredient: | macitentan; tadalafil |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218490
Generic Entry Date for 218490*:
Constraining patent/regulatory exclusivity:
CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III) 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: 218490
| Mechanism of Action | Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 218490
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812 | 66215-812-07 | 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE |
| OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812 | 66215-812-08 | 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
| Approval Date: | Mar 22, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2031 | ||||||||
| Regulatory Exclusivity Use: | CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF THE COMBINATION OF MACITENTAN AND TADALAFIL FOR THE CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | ||||||||
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