macitentan · Actelion · NDA 204410
Opsumit
Earliest generic entry, as listed
18 Oct 2029
Blocked by patent: US 8268847.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8268847 | — | 18 Oct 2029 |
| US 8268847 | use U-1446 | 18 Apr 2029 |
| US 8367685 | — | 4 Apr 2029 |
| US 8367685 | product, use U-1445 | 4 Oct 2028 |
| US 9265762 | — | 29 Nov 2027 |
| US 9265762 | product, use U-1820 | 29 May 2027 |
| US 10946015 | — | 11 Mar 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 28 Aug 2028 |
| M-187 | miscellaneous (3 years) | 28 Feb 2028 |
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
- 25 Oct 2026Generic approved · 204410-0013 Dec 2025
- 25 Oct 2026Generic approved · 204410-0018 Jun 2026
- 25 Oct 2026Generic approved · 204410-0015 Nov 2025
- 25 Oct 2026Generic approved · 204410-0018 Jun 2026
- 25 Oct 2026Generic approved · 204410-0013 Dec 2025
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204410 · 001 · RLD | tablet, oral | 10MG | 18 Oct 2029 |
Expired or delisted (3)
- US 10946015 · product, use U-1445 · 11 Sep 2026
- US 7094781 · — · 5 Jun 2026
- US 7094781 · substance, product · 5 Dec 2025