NDAORALTABLET
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
2
Mechanism of Action
Phosphodiesterase 5 Inhibitors
Pharmacologic Class:
Phosphodiesterase 5 Inhibitor
Clinical Trials (2)
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 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
Sep 22, 2031
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7094781 | Dec 5, 2025Expired | SubstanceProduct | — |
| 7094781*PED | Jun 5, 2026 | — | |
| 10946015 | Sep 11, 2026 | Product | U-3881 |
| 10946015*PED | Mar 11, 2027 | — | |
| 8268847 | Apr 18, 2029 | Product | U-3882 |