Details for New Drug Application (NDA): 204410
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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: | ⤷ Subscribe | 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: | ⤷ Subscribe | Patent Expiration: | Dec 5, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Subscribe | 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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