FDA Orange Book · active-ingredient family
Finerenone
Finerenone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KERENDIA · NDA 215341
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KERENDIARLD×3 | BAYER HLTHCARE | NDA 215341 | — | Jul 09, 2021 |
Marketing exclusivity (6)
- I-970New indication exclusivity (3 years)
Jul 11, 2028
in 2 yr 1 mo
- 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
- NCENew chemical entity exclusivity (5 years)
Jul 09, 2026
in 20 d
- NCENew chemical entity exclusivity (5 years)
Jul 09, 2026
in 20 d
- NSNew strength 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 |
Finerenone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
