FDA Orange Book
Is there a generic for Brenzavvy?
Brenzavvy contains bexagliflozin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brenzavvy (bexagliflozin). The Orange Book shows its last listed patent expires October 5, 2041 and its last listed exclusivity ends January 20, 2028.
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Brenzavvy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
NDA 214373, held by THERACOSBIO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Brenzavvy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8802637 | August 22, 2028 | Drug substance, Drug product | U-2214 | 214373 |
| 8106021 | August 22, 2028 | Method of use | U-2214 | 214373 |
| 7838499 | January 30, 2029 | Drug substance, Drug product | U-2214 | 214373 |
| 10981942 | June 13, 2031 | Drug substance, Drug product | None | 214373 |
| 10533032 | July 3, 2031 | Method of use | U-2214 | 214373 |
| 8987323 | May 14, 2032 | Drug substance, Drug product | None | 214373 |
| 12594243 | October 5, 2041 | Drug product | None | 214373 |
Brenzavvy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 20, 2028 | 214373 |
Brenzavvy NDC codes
Questions
Is there a generic for Brenzavvy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brenzavvy (bexagliflozin). The Orange Book shows its last listed patent expires October 5, 2041 and its last listed exclusivity ends January 20, 2028.
What is the generic name for Brenzavvy?
The active ingredient in Brenzavvy is bexagliflozin, per the FDA Orange Book.
When does the Brenzavvy patent expire?
The last patent listed for Brenzavvy in the Orange Book expires October 5, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.