macitentan; tadalafil · Actelion · NDA 218490
Opsynvi
Earliest generic entry, as listed · earliest of 2 marketed strengths
22 Sep 2031
Blocked by exclusivity: PED.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8268847 | — | 18 Oct 2029 |
| US 8268847 | product, use U-3882 | 18 Apr 2029 |
| US 10946015 | — | 11 Mar 2027 |
Exclusivities · 4 unexpired
| PED | pediatric (6 months added) | 22 Sep 2031 |
| ODE-475 | orphan drug (7 years) | 22 Mar 2031 |
| PED | pediatric (6 months added) | 22 Sep 2027 |
| NP | new product | 22 Mar 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218490 · 001 · RLD | tablet, oral | 10MG;20MG | 22 Sep 2031 |
| 218490 · 002 · RLD | tablet, oral | 10MG;40MG | 22 Sep 2031 |
Expired or delisted (3)
- US 10946015 · product, use U-3881 · 11 Sep 2026
- US 7094781 · — · 5 Jun 2026
- US 7094781 · substance, product · 5 Dec 2025