cliffwatch

cabozantinib s-malate · Exelixis Inc · NDA 208692

Cabometyx

Earliest generic entry, as listed · earliest of 3 marketed strengths
9 Jul 2033

Blocked by patent: US 9724342.

Listed patents · 19 unexpired

PatentClaimsExpires
US 9724342product9 Jul 2033
US 11298349product10 Feb 2032
US 12128039product, use U-148010 Feb 2032
US 12128039product, use U-248810 Feb 2032
US 12128039product, use U-322510 Feb 2032
US 12128039product, use U-413110 Feb 2032
US 12128039product, use U-415610 Feb 2032
US 12128039product, use U-122010 Feb 2032
US 10034873use U-248818 Jul 2031
US 10039757use U-148018 Jul 2031
US 8877776substance, product, use U-32258 Oct 2030
US 11091439substance15 Jan 2030
US 11091440product15 Jan 2030
US 11098015use U-322515 Jan 2030
US 11098015use U-415615 Jan 2030
US 11098015use U-413115 Jan 2030
US 11098015use U-248815 Jan 2030
US 11098015use U-148015 Jan 2030
US 11098015use U-122015 Jan 2030

Exclusivities · 2 unexpired

ODE-530orphan drug (7 years)26 Mar 2032
ODE-375orphan drug (7 years)17 Sep 2028

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 · 208692-001
  • 25 Oct 2026Generic approved · 208692-001
  • 25 Oct 2026Generic approved · 208692-001

Products covered · 3

NDA · productFormStrengthListed expiry
208692 · 001 · RLDtablet, oralEQ 20MG BASE9 Jul 2033
208692 · 002 · RLDtablet, oralEQ 40MG BASE9 Jul 2033
208692 · 003 · RLDtablet, oralEQ 60MG BASE9 Jul 2033
Expired or delisted (2)
  • US 7579473 · substance, product · 14 Aug 2026
  • ODE-227 · 14 Jan 2026