FDA Orange Book · active-ingredient family
Sitagliptin hydrochloride
Sitagliptin hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BRYNOVIN · NDA 219122
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRYNOVINRLD | AZURITY | NDA 219122 | — | Jan 16, 2025 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12295953 | Oct 23, 2040 | in 14 yr 7 mo | Product |
| 11944621 | Oct 23, 2040 | in 14 yr 7 mo | Product |
Sitagliptin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
