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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 662150501 | Opsumit | NDA | Actelion Pharmaceuticals Us, Inc. | 2013-10-01 | MACITENTAN | ORAL | TABLET, FILM COATED | NDA204410 | 1e484a50-55db-4b85-8c57-6cd1b0353abd |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA204410 | OPSUMIT | ACTELION PHARMACEUTICALS LTD | 2013-10-18 | p7094781, 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)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA204410_001 | RX | MACITENTAN (10MG) | ORAL | TABLET | True | 2013-10-18 | OPSUMIT |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7094781 (view patent) | 2022-10-12 | NDA204410 |
| 2 | p8268847 (view patent) | 2029-04-18 | NDA204410 |
| 3 | p8367685 (view patent) | 2028-10-04 | NDA204410 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1e484a50-55db-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: 2013 | prescription | Human Prescription | Actelion Pharmaceuticals Us, Inc. | MANUFACTURE | 2015-05-14 | 6 | 662150501 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII