FDA Orange Book · active-ingredient family
Sitagliptin
Sitagliptin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZITUVIO · NDA 211566
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZITUVIORLD×3 | ZYDUS LIFESCIENCES | NDA 211566 | — | Oct 18, 2023 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10925871 | Feb 25, 2035 | in 8 yr 10 mo | Product |
Sitagliptin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
