FDA Orange Book · active-ingredient family
Metformin hydrochloride; saxagliptin hydrochloride
Metformin hydrochloride; saxagliptin hydrochloride 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:KOMBIGLYZE XR · NDA 200678
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
3
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KOMBIGLYZE XRRLD×3 | ASTRAZENECA AB | NDA 200678 | — | Nov 05, 2010 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE×3 | DR REDDYS LABS SA | ANDA 207678 | AB | Aug 09, 2023 | |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE×3 | MYLAN | ANDA 205981 | AB | Jul 31, 2023 | |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE×3 | SUN PHARM | ANDA 206081 | — | Jul 31, 2023 |
Marketing exclusivity (3)
- M-14New use / labeling-change exclusivity (3 years)
Oct 11, 2027
in 1 yr 4 mo
- M-14New use / labeling-change exclusivity (3 years)
Oct 11, 2027
in 1 yr 4 mo
- M-14New use / labeling-change exclusivity (3 years)
Oct 11, 2027
in 1 yr 4 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Metformin hydrochloride; saxagliptin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
