metformin hydrochloride; sitagliptin phosphate · Msd Sub Merck · NDA 022044
Janumet
Blocked by patent: US 8414921 (pediatric extension).
FDA has approved 2 generic applications (ANDAs) for Janumet, though its earliest generic-entry date is 21 Jan 2029 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 · 2 unexpired
4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8414921 | drug product, use U-1036 | 21 Jan 2029 |
| US 8414921 listing row | drug product, use U-1036 | 21 Jul 2028 |
| US 8414921 listing row | pediatric extension · sets the listed date | 21 Jan 2029 |
| US 7326708 | drug substance, drug product, use U-802 | 24 May 2027 |
| US 7326708 listing row | drug substance, drug product, use U-802 | 24 Nov 2026 |
| US 7326708 listing row | pediatric extension | 24 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
- Generic approved · ANDA 202426, Apotex · 022044-001Approved 30 Apr 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 208535, Zydus Pharms Usa Inc · 022044-001Tentative approval 30 Jun 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 202388, Sandoz · 022044-001Approved 2 Dec 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 202388, Sandoz · 022044-001Approved 2 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022044 · 001 · RLD | tablet, oral | 500MG;EQ 50MG BASE | 21 Jan 2029 |
| 022044 · 002 · RLD | tablet, oral | 1GM;EQ 50MG BASE | 21 Jan 2029 |