NDAORALTABLET
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
5
Mechanism of Action
Endothelin Receptor Antagonists
Pharmacologic Class:
Endothelin Receptor Antagonist
Clinical Trials (5)
A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
Started Nov 2022
7 enrolled
Pulmonary Arterial Hypertension
A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
Started Apr 2021
18 enrolled
Healthy
A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag
Started Oct 2020
372 enrolled
Pulmonary Arterial Hypertension
A Study of Macitentan, in Healthy Japanese Male Participants
Started Jul 2020
24 enrolled
Healthy
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Started Jan 2020
62 enrolled
Healthy
Loss of Exclusivity
LOE Date
Oct 18, 2029
44 months away
Patent Expiry
Oct 18, 2029
Exclusivity Expiry
Aug 28, 2028
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7094781 | Dec 5, 2025Expired | SubstanceProduct | — |
| 7094781*PED | Jun 5, 2026 | — | |
| 10946015 | Sep 11, 2026 | Product | U-1445 |
| 10946015*PED | Mar 11, 2027 | — | |
| 9265762 | May 29, 2027 | Product | U-1820 |