FDA Orange Book · active-ingredient family
Sitagliptin phosphate
Sitagliptin phosphate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:JANUVIA · NDA 021995
1
Brand (NDA)
3
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JANUVIARLD×3 | MSD | NDA 021995 | AB | Oct 16, 2006 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE×3 | APOTEX | ANDA 202425 | AB | Jan 20, 2026 | |
| SITAGLIPTIN PHOSPHATE×3 | SANDOZ | ANDA 202387 | AB | Jan 14, 2026 | |
| SITAGLIPTIN PHOSPHATE×3 | WATSON LABS INC | ANDA 202327 | AB | Dec 30, 2025 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | Nov 24, 2026 | in 5 mo | SubstanceProductU-802 |
| 7326708*PED | May 24, 2027 | in 11 mo |
Sitagliptin phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
