Orange Book product · Brand (NDA)
BAXFENDY
BAXDROSTAT
Brand (NDA)NDA 219878RX ASTRAZENECA AB
At a glance
May 15, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 2026
1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 15, 2031
in 5 yr
Patent 9353081 expires
Listed drug substance patent expiration.
Feb 04, 2033
in 6 yr 9 mo
Pharmaceutical detail
Active ingredient
BAXDROSTAT
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219878
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
May 15, 2031
in 5 yr
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9353081 | Feb 04, 2033 | in 6 yr 9 mo | SubstanceProduct |
