Orange Book product · Brand (NDA)
BRENZAVVY
BEXAGLIFLOZIN
At a glance
Jan 20, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 20, 2023
3 yr 6 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 20, 2028
in 1 yr 7 mo
Patent 8106021 expires
Listed method-of-use patent (U-2214) expiration.
Aug 22, 2028
in 2 yr 3 mo
Patent 8802637 expires
Listed drug substance patent expiration.
Aug 22, 2028
in 2 yr 3 mo
Patent 7838499 expires
Listed drug substance patent expiration.
Jan 30, 2029
in 2 yr 8 mo
Patent 10981942 expires
Listed drug substance patent expiration.
Jun 13, 2031
in 5 yr 1 mo
Patent 10533032 expires
Listed method-of-use patent (U-2214) expiration.
Jul 03, 2031
in 5 yr 1 mo
Patent 8987323 expires
Listed drug substance patent expiration.
May 14, 2032
in 6 yr
Patent 12594243 expires
Listed drug product patent expiration.
Oct 05, 2041
in 15 yr 6 mo
Pharmaceutical detail
Active ingredient
BEXAGLIFLOZIN
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214373
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jan 20, 2028
in 1 yr 7 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8106021 | Aug 22, 2028 | in 2 yr 3 mo | U-2214 |
| 8802637 | Aug 22, 2028 | in 2 yr 3 mo | SubstanceProductU-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 |
