FDA Orange Book · active-ingredient family
Ertugliflozin
Ertugliflozin 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:STEGLATRO · NDA 209803
1
Brand (NDA)
3
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STEGLATRORLD×2 | MSD SUB MERCK | NDA 209803 | — | Dec 19, 2017 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERTUGLIFLOZIN×2 | HIKMA | ANDA 216842 | — | Jan 21, 2025 | |
| ERTUGLIFLOZIN×2 | HETERO LABS LTD V | ANDA 217071 | — | Sep 17, 2024 | |
| ERTUGLIFLOZIN×2 | AUROBINDO PHARMA LTD | ANDA 216947 | — | Jul 13, 2023 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8080580 | Dec 19, 2031 | in 5 yr 7 mo | SubstanceProductU-2214 |
Ertugliflozin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
