cliffwatch

sitagliptin phosphate · Msd · NDA 021995

Januvia

Earliest generic entry, as listed · earliest of 3 marketed strengths
24 May 2027

Blocked by patent: US 7326708.

Listed patents · 2 unexpired

PatentClaimsExpires
US 7326708—24 May 2027
US 7326708substance, product, use U-80224 Nov 2026

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 2026Generic tentatively approved · 021995-001
  • 25 Oct 2026Generic approved · 021995-001
  • 25 Oct 2026Generic approved · 021995-001
  • 25 Oct 2026Generic tentatively approved · 021995-001
  • 25 Oct 2026First generic approved · 021995-001
  • 25 Oct 2026Generic approved · 021995-001
  • 25 Oct 2026Generic tentatively approved · 021995-001
  • 25 Oct 2026Generic tentatively approved · 021995-001
  • 24 Oct 2026Enters 12-month window basis: patent · 021995-003
  • 24 Oct 2026Enters 12-month window basis: patent · 021995-002
  • 24 Oct 2026Enters 12-month window basis: patent · 021995-001

Products covered · 3

NDA · productFormStrengthListed expiry
021995 · 001 · RLDtablet, oralEQ 25MG BASE24 May 2027
021995 · 002 · RLDtablet, oralEQ 50MG BASE24 May 2027
021995 · 003 · RLDtablet, oralEQ 100MG BASE24 May 2027