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 (pediatric extension).

FDA has approved 3 generic applications (ANDAs) for Januvia, though its earliest generic-entry date is 24 May 2027 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 · 1 unexpired

2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 7326708drug substance, drug product, use U-80224 May 2027
US 7326708 listing rowdrug substance, drug product, use U-80224 Nov 2026
US 7326708 listing rowpediatric extension · sets the listed date24 May 2027

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