belzutifan · Merck Sharp Dohme · NDA 215383
Welireg
Earliest generic entry, as listed
30 Jun 2042
Blocked by patent: US 12358870.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12358870 | product | 30 Jun 2042 |
| US 10335388 | use U-4565 | 14 Apr 2036 |
| US 9908845 | substance, product, use U-4195 | 5 Sep 2034 |
| US 9908845 | substance, product, use U-4565 | 5 Sep 2034 |
| US 9908845 | substance, product, use U-4176 | 5 Sep 2034 |
| US 9908845 | substance, product, use U-3201 | 5 Sep 2034 |
| US RE49948 | substance, product, use U-3201 | 5 Sep 2034 |
| US RE49948 | substance, product, use U-4176 | 5 Sep 2034 |
| US RE49948 | substance, product, use U-4195 | 5 Sep 2034 |
| US RE49948 | substance, product, use U-4565 | 5 Sep 2034 |
Exclusivities · 4 unexpired
| I-994 | new indication (3 years) | 12 Jun 2029 |
| ODE-364 | orphan drug (7 years) | 13 Aug 2028 |
| I-968 | new indication (3 years) | 14 May 2028 |
| I-931 | new indication (3 years) | 14 Dec 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days I-931 · 215383-00114 Dec 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215383 · 001 · RLD | tablet, oral | 40MG | 30 Jun 2042 |
Expired or delisted (1)
- NCE · 13 Aug 2026