cliffwatch

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

PatentClaimsExpires
US 12252479use U-1374 · sets the listed date17 May 2040
US 11407735drug substance14 May 2040
US 12252478drug product14 May 2040
US 8829195drug substance, use U-137429 Oct 2035

Exclusivities · 9 unexpired

ODE-499orphan drug (7 years)29 Oct 2031
ODE-500orphan drug (7 years)29 Oct 2031
ODE-381orphan drug (7 years)29 Oct 2028
ODE-382orphan drug (7 years)29 Oct 2028
ODE*29 Oct 2028
M-318miscellaneous (3 years)2 Oct 2028
I-954new indication (3 years)29 Oct 2027
I-953new indication (3 years)29 Oct 2027
NCEnew 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 · 215358-003
  • 24 Oct 2026Exclusivity expires within 90 days NCE · 215358-002
  • 24 Oct 2026Exclusivity expires within 90 days NCE · 215358-001

Products covered · 3

NDA · productFormStrengthListed expiry
215358 · 001 · RLDtablet, oralEQ 20MG BASE17 May 2040
215358 · 002 · RLDtablet, oralEQ 40MG BASE17 May 2040
215358 · 003 · RLDtablet, oralEQ 100MG BASE17 May 2040