Details for New Drug Application (NDA): 204410
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NDA 204410 describes OPSUMIT, which is a drug marketed by Actelion and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OPSUMIT profile page.
The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.
The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.
Summary for 204410
| Tradename: | OPSUMIT |
| Applicant: | Actelion |
| Ingredient: | macitentan |
| Patents: | 5 |
Pharmacology for NDA: 204410
| Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 204410
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPSUMIT | macitentan | TABLET;ORAL | 204410 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-501 | 66215-501-15 | 1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK |
| OPSUMIT | macitentan | TABLET;ORAL | 204410 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-501 | 66215-501-30 | 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 18, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHEREIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 5, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 18, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES | ||||||||
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