Macitentan Oral Tablet

Brand(s)
Opsumit
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actelion Pharmaceuticals Us, Inc. (2015-05-14)
Oldest Current Product
2013-10-01
License(s)
NDA
RxNORM
ORAL TABLET\MACITENTAN
FDAOB
ORAL\TABLET\MACITENTAN
SPL Active
ORAL\TABLET, FILM COATED\MACITENTAN
SPL Moiety
ORAL\TABLET, FILM COATED\MACITENTAN

product(s) by strength(s)

macitentan 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1662150501OpsumitNDAActelion Pharmaceuticals Us, Inc.2013-10-01MACITENTANORALTABLET, FILM COATEDNDA2044101e484a50-55db-4b85-8c57-6cd1b0353abd

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204410OPSUMITACTELION PHARMACEUTICALS LTD2013-10-18p7094781, SUBSTANCE
p8367685, METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, SUBSTANCE
p8268847, METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
NEW CHEMICAL ENTITY [2018-10-18]
ORPHAN DRUG EXCLUSIVITY [2020-10-18]
NDA204410_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204410_001RXMACITENTAN (10MG)ORALTABLETTrue2013-10-18OPSUMIT

patent(s)

#idexpiration dateapplication(s)
1p7094781 (view patent)2022-10-12NDA204410
2p8268847 (view patent)2029-04-18NDA204410
3p8367685 (view patent)2028-10-04NDA204410

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11e484a50-55db-4b85-8c57-6cd1b0353abd (view SPL)These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT (macitentan) tablets, for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionActelion Pharmaceuticals Us, Inc.MANUFACTURE2015-05-146662150501

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII