FDA Orange Book
Is there a generic for Baxfendy?
Baxfendy contains baxdrostat. 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 Baxfendy (baxdrostat). The Orange Book shows its last listed patent expires February 4, 2033 and its last listed exclusivity ends May 15, 2031.
Run it in Rivvi
Map Baxfendy and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Baxfendy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
NDA 219878, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Baxfendy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9353081 | February 4, 2033 | Drug substance, Drug product | None | 219878 |
Baxfendy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 15, 2031 | 219878 |
Baxfendy NDC codes
Questions
Is there a generic for Baxfendy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Baxfendy (baxdrostat). The Orange Book shows its last listed patent expires February 4, 2033 and its last listed exclusivity ends May 15, 2031.
What is the generic name for Baxfendy?
The active ingredient in Baxfendy is baxdrostat, per the FDA Orange Book.
When does the Baxfendy patent expire?
The last patent listed for Baxfendy in the Orange Book expires February 4, 2033. 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.