asciminib hydrochloride · Novartis · NDA 215358
Scemblix
Earliest generic entry, as listed · earliest of 3 marketed strengths
17 May 2040
Blocked by patent: US 12252479. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12252479 | use U-1374 | 17 May 2040 |
| US 11407735 | substance | 14 May 2040 |
| US 12252478 | product | 14 May 2040 |
| US 8829195 | substance, use U-1374 | 29 Oct 2035 |
Exclusivities · 9 unexpired
| ODE-499 | orphan drug (7 years) | 29 Oct 2031 |
| ODE-500 | orphan drug (7 years) | 29 Oct 2031 |
| ODE-381 | orphan drug (7 years) | 29 Oct 2028 |
| ODE-382 | orphan drug (7 years) | 29 Oct 2028 |
| ODE* | 29 Oct 2028 | |
| M-318 | miscellaneous (3 years) | 2 Oct 2028 |
| I-954 | new indication (3 years) | 29 Oct 2027 |
| I-953 | new indication (3 years) | 29 Oct 2027 |
| NCE | new chemical entity (5 years) | 29 Oct 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 NCE · 215358-00329 Oct 2026
- 24 Oct 2026Exclusivity expires within 90 days NCE · 215358-00229 Oct 2026
- 24 Oct 2026Exclusivity expires within 90 days NCE · 215358-00129 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215358 · 001 · RLD | tablet, oral | EQ 20MG BASE | 17 May 2040 |
| 215358 · 002 · RLD | tablet, oral | EQ 40MG BASE | 17 May 2040 |
| 215358 · 003 · RLD | tablet, oral | EQ 100MG BASE | 17 May 2040 |