cliffwatch

venetoclax · Abbvie · NDA 208573

Venclexta

Earliest generic entry, as listed · earliest of 3 marketed strengths
6 Sep 2033

Blocked by patent: US 10993942, US 11110087, US 11110087, US 11413282, US 11590128, US 9539251. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

FDA has approved 1 generic application (ANDA) for Venclexta, though its earliest generic-entry date is 6 Sep 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 14 unexpired

PatentClaimsExpires
US 10993942use U-31146 Sep 2033
US 11110087use U-32226 Sep 2033
US 11110087use U-32236 Sep 2033
US 11413282use U-34126 Sep 2033
US 11590128use U-35486 Sep 2033
US 9539251use U-25386 Sep 2033
US 11369599product23 May 2032
US 8722657substance29 Jan 2032
US 10730873substance21 Nov 2031
US 8546399substance, product27 Jun 2031
US 9174982use U-253726 May 2030
US 9174982use U-244626 May 2030
US 9174982use U-232326 May 2030
US 9174982use U-244526 May 2030

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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 2026First generic approved · 208573-001
  • 25 Oct 2026Generic approved · 208573-001

Products covered · 3

NDA · productFormStrengthListed expiry
208573 · 001 · RLDtablet, oral10MG6 Sep 2033
208573 · 002 · RLDtablet, oral50MG6 Sep 2033
208573 · 003 · RLDtablet, oral100MG6 Sep 2033
Expired or delisted (1)
  • ODE-239 · 15 May 2026