metformin hydrochloride; sitagliptin phosphate · Msd Sub Merck · NDA 022044
Janumet
Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Jan 2029
Blocked by patent: US 8414921.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8414921 | — | 21 Jan 2029 |
| US 8414921 | product, use U-1036 | 21 Jul 2028 |
| US 7326708 | — | 24 May 2027 |
| US 7326708 | substance, product, use U-802 | 24 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 approved · 022044-00130 Apr 2026
- 25 Oct 2026Generic tentatively approved · 022044-00130 Jun 2026
- 25 Oct 2026First generic approved · 022044-0012 Dec 2025
- 25 Oct 2026Generic approved · 022044-0012 Dec 2025
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 |