avapritinib · Blueprint Medicines · NDA 212608
Ayvakit
Earliest generic entry, as listed · earliest of 5 marketed strengths
10 Apr 2040
Other strengths are listed to 8 Mar 2042.
Blocked by patent: US 11964980, US 11999744, US 11999744, US 12252494.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12060354 | use U-2726 | 8 Mar 2042 |
| US 11964980 | substance, product | 10 Apr 2040 |
| US 11999744 | use U-3168 | 10 Apr 2040 |
| US 11999744 | use U-3506 | 10 Apr 2040 |
| US 12252494 | use U-3506 | 10 Apr 2040 |
| US 11827642 | substance, product, use U-3506 | 15 Oct 2034 |
| US 9200002 | substance, product, use U-2726 | 15 Oct 2034 |
| US 9200002 | substance, product, use U-3168 | 15 Oct 2034 |
| US 9200002 | substance, product, use U-3506 | 15 Oct 2034 |
| US 9944651 | substance, product, use U-3168 | 15 Oct 2034 |
| US 9944651 | substance, product, use U-3506 | 15 Oct 2034 |
| US 9944651 | substance, product, use U-2726 | 15 Oct 2034 |
| US 9994575 | substance, product, use U-3506 | 15 Oct 2034 |
| US 9994575 | substance, product, use U-3168 | 15 Oct 2034 |
| US 9994575 | substance, product, use U-2726 | 15 Oct 2034 |
Exclusivities · 3 unexpired
| ODE-434 | orphan drug (7 years) | 22 May 2030 |
| ODE-356 | orphan drug (7 years) | 16 Jun 2028 |
| ODE-366 | orphan drug (7 years) | 9 Jan 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
- 24 Oct 2026Exclusivity expires within 90 days ODE-366 · 212608-0039 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-366 · 212608-0029 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-366 · 212608-0019 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-366 · 212608-0059 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-366 · 212608-0049 Jan 2027
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212608 · 001 · RLD | tablet, oral | 100MG | 8 Mar 2042 |
| 212608 · 002 · RLD | tablet, oral | 200MG | 8 Mar 2042 |
| 212608 · 003 · RLD | tablet, oral | 300MG | 8 Mar 2042 |
| 212608 · 004 · RLD | tablet, oral | 25MG | 10 Apr 2040 |
| 212608 · 005 · RLD | tablet, oral | 50MG | 10 Apr 2040 |
Expired or delisted (1)
- I-912 · 22 May 2026