cliffwatch

valbenazine tosylate · Neurocrine · NDA 209241

Ingrezza

Earliest generic entry, as listed · earliest of 3 marketed strengths
10 Aug 2040

Blocked by patent: US 10940141. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 33 unexpired

PatentClaimsExpires
US 10940141use U-199510 Aug 2040
US 11026931use U-199514 Aug 2039
US 11654142use U-305514 Nov 2038
US 11026939product, use U-305518 Sep 2038
US 11026939product, use U-199518 Sep 2038
US 11311532product, use U-305518 Sep 2038
US 11311532product, use U-199518 Sep 2038
US 10857137use U-199510 Oct 2037
US 10857148use U-199510 Oct 2037
US 10874648use U-305510 Oct 2037
US 10874648use U-304610 Oct 2037
US 10874648use U-199510 Oct 2037
US 10912771use U-307610 Oct 2037
US 10912771use U-305510 Oct 2037
US 10912771use U-199510 Oct 2037
US 10952997use U-199510 Oct 2037
US 10993941use U-199510 Oct 2037
US 11040029use U-199510 Oct 2037
US 11439629use U-305510 Oct 2037
US 10906902substance, product22 Dec 2036
US 10906903substance, product22 Dec 2036
US 10919892substance, product22 Dec 2036
US 10065952substance, product, use U-199528 Oct 2036
US 10065952substance, product, use U-305528 Oct 2036
US 10844058substance, product, use U-305528 Oct 2036
US 10844058substance, product, use U-199528 Oct 2036
US 10851103substance, product, use U-305528 Oct 2036
US 10851103substance, product, use U-199528 Oct 2036
US 10851104substance, use U-305528 Oct 2036
US 10851104substance, use U-199528 Oct 2036
US 8039627substance, product11 Apr 2031
US 8357697use U-19958 Nov 2027
US 8357697use U-30558 Nov 2027

Exclusivities · 1 unexpired

ODE-440orphan drug (7 years)18 Aug 2030

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 · 209241-001

Products covered · 3

NDA · productFormStrengthListed expiry
209241 · 001 · RLDcapsule, oralEQ 40MG BASE10 Aug 2040
209241 · 002 · RLDcapsule, oralEQ 80MG BASE10 Aug 2040
209241 · 003 · RLDcapsule, oralEQ 60MG BASE10 Aug 2040
Expired or delisted (1)
  • I-925 · 18 Aug 2026