Orange Book product · Brand (NDA)
KERENDIA
FINERENONE
At a glance
Jul 09, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2021
5 yr ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 09, 2026
in 20 d
Exclusivity ends · I-970
New indication exclusivity (3 years)
Jul 11, 2028
in 2 yr 1 mo
Patent 8436180 expires
Listed drug substance patent expiration.
Aug 26, 2033
in 7 yr 4 mo
Patent RE49826 expires
Listed drug substance patent expiration.
Jul 29, 2035
in 9 yr 3 mo
Pharmaceutical detail
Active ingredient
FINERENONE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215341
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 (2)
- NCENew chemical entity exclusivity (5 years)
Jul 09, 2026
in 20 d
- I-970New indication exclusivity (3 years)
Jul 11, 2028
in 2 yr 1 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8436180 | Aug 26, 2033 | in 7 yr 4 mo | SubstanceProduct |
| RE49826 | Jul 29, 2035 | in 9 yr 3 mo | Substance |
