vonoprazan fumarate · Phathom · NDA 215151

Voquezna

Earliest generic entry, as listed · earliest of 2 marketed strengths
3 May 2032

Blocked by exclusivity: GAIN.

Listed patents · 2 unexpired

PatentClaimsExpires
US 9186411product11 Aug 2030
US 7977488substance10 Apr 2030

Exclusivities · 4 unexpired

GAINqualified infectious disease product3 May 2032
I-948new indication (3 years)17 Jul 2027
NCEnew chemical entity (5 years)3 May 2027
NPnew product1 Nov 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 NP · 215151-002
  • 24 Oct 2026Exclusivity expires within 90 days NP · 215151-001

Products covered · 2

NDA · productFormStrengthListed expiry
215151 · 001 · RLDtablet, oralEQ 10MG BASE3 May 2032
215151 · 002 · RLDtablet, oralEQ 20MG BASE3 May 2032