FDA Orange Book
Is there a generic for Kerendia?
Kerendia contains finerenone. 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 Kerendia (finerenone). The Orange Book shows its last listed patent expires July 29, 2035 and its last listed exclusivity ends September 16, 2029.
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Kerendia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 215341, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kerendia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8436180 | August 26, 2033 | Drug substance, Drug product | None | 215341 |
| RE49826 | July 29, 2035 | Drug substance | None | 215341 |
Kerendia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 9, 2026 | 215341 |
| I-970 | New indication | July 11, 2028 | 215341 |
| NS | New strength | July 11, 2028 | 215341 |
| I-998 | New indication | September 16, 2029 | 215341 |
Kerendia NDC codes
Questions
Is there a generic for Kerendia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kerendia (finerenone). The Orange Book shows its last listed patent expires July 29, 2035 and its last listed exclusivity ends September 16, 2029.
What is the generic name for Kerendia?
The active ingredient in Kerendia is finerenone, per the FDA Orange Book.
When does the Kerendia patent expire?
The last patent listed for Kerendia in the Orange Book expires July 29, 2035. 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.
More on Kerendia and Finerenone
- What is Kerendia used for?FDA label uses
- Is Kerendia a controlled substance?Federal schedule
- Nonsteroidal Mineralocorticoid-Receptor Antagonists listFDA drug class
- Kerendia Medicare Part D coverageBy plan and state
- NDC 50419-540Kerendia NDC record
- NDC 50419-541Kerendia NDC record
- NDC 50419-542Kerendia NDC record