FDA Orange Book · active-ingredient family
Metformin hydrochloride; sitagliptin phosphate
Metformin hydrochloride; sitagliptin phosphate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:JANUMET XR · NDA 202270
2
Brand (NDA)
3
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JANUMET XRRLD×3 | MSD SUB MERCK | NDA 202270 | AB | Feb 02, 2012 | |
| JANUMETRLD×2 | MSD SUB MERCK | NDA 022044 | AB | Mar 30, 2007 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE×2 | APOTEX | ANDA 202426 | AB | Apr 30, 2026 | |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE×2 | SANDOZ | ANDA 202388 | AB | Dec 02, 2025 | |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE×3 | PH HEALTH | ANDA 204144 | AB | Jun 04, 2025 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | Nov 24, 2026 | in 5 mo | SubstanceProductU-1227 |
| 7326708*PED | May 24, 2027 | in 11 mo | |
| 8414921 | Jul 21, 2028 | in 2 yr 1 mo | ProductU-1036 |
| 8414921*PED | Jan 21, 2029 | in 2 yr 8 mo |
Metformin hydrochloride; sitagliptin phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
