FDA Orange Book · active-ingredient family
Bexagliflozin
Bexagliflozin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BRENZAVVY · NDA 214373
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
1
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRENZAVVYRLD | THERACOSBIO | NDA 214373 | — | Jan 20, 2023 |
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jan 20, 2028
in 1 yr 7 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8802637 | Aug 22, 2028 | in 2 yr 3 mo | SubstanceProductU-2214 |
| 8106021 | Aug 22, 2028 | in 2 yr 3 mo | U-2214 |
| 7838499 | Jan 30, 2029 | in 2 yr 8 mo | SubstanceProductU-2214 |
| 10981942 | Jun 13, 2031 | in 5 yr 1 mo | SubstanceProduct |
| 10533032 | Jul 03, 2031 | in 5 yr 1 mo | U-2214 |
| 8987323 | May 14, 2032 | in 6 yr | SubstanceProduct |
| 12594243 | Oct 05, 2041 | in 15 yr 6 mo | Product |
Bexagliflozin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
