FDA Orange Book · active-ingredient family
Saxagliptin hydrochloride
Saxagliptin hydrochloride is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ONGLYZA · NDA 022350
1
Brand (NDA)
5
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ONGLYZARLD×2 | ASTRAZENECA AB | NDA 022350 | — | Jul 31, 2009 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAXAGLIPTIN×2 | AMNEAL | ANDA 205941 | — | Jul 31, 2023 | |
| SAXAGLIPTIN×2 | AUROBINDO PHARMA | ANDA 205972 | AB | Jul 31, 2023 | |
| SAXAGLIPTIN×2 | GLENMARK PHARMS LTD | ANDA 205994 | AB | Jul 31, 2023 | |
| SAXAGLIPTIN×2 | MYLAN | ANDA 205980 | AB | Jul 31, 2023 | |
| SAXAGLIPTIN×2 | SUN PHARM | ANDA 206078 | — | Jul 31, 2023 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7951400 | Nov 30, 2028 | in 2 yr 6 mo | Product |
Saxagliptin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
