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Last Updated: June 14, 2024

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.
Summary for 204410
Tradename:OPSUMIT
Applicant:Actelion
Ingredient:macitentan
Patents:5
Pharmacology for NDA: 204410
Mechanism of ActionEndothelin 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:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 18, 2013TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Sep 11, 2026Product Flag?YSubstance 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 UpPatent Expiration:Dec 5, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 18, 2029Product 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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