pemigatinib · Incyte Corp · NDA 213736
Pemazyre
Earliest generic entry, as listed · earliest of 3 marketed strengths
3 Oct 2040
Blocked by patent: US 12552792.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12552792 | substance, product | 3 Oct 2040 |
| US 11628162 | use U-3571 | 30 Aug 2040 |
| US 11628162 | use U-3569 | 30 Aug 2040 |
| US 11628162 | use U-3568 | 30 Aug 2040 |
| US 11628162 | use U-3570 | 30 Aug 2040 |
| US 11466004 | use U-3464 | 3 May 2039 |
| US 11466004 | use U-3465 | 3 May 2039 |
| US 11466004 | use U-3466 | 3 May 2039 |
| US 9611267 | substance, product | 30 Jan 2035 |
| US 10131667 | use U-2809 | 17 Apr 2034 |
Exclusivities · 2 unexpired
| ODE-404 | orphan drug (7 years) | 26 Aug 2029 |
| ODE-292 | orphan drug (7 years) | 17 Apr 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
- 25 Oct 2026Generic tentatively approved · 213736-0011 Jun 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213736 · 001 · RLD | tablet, oral | 4.5MG | 3 Oct 2040 |
| 213736 · 002 · RLD | tablet, oral | 9MG | 3 Oct 2040 |
| 213736 · 003 · RLD | tablet, oral | 13.5MG | 3 Oct 2040 |