finerenone · Bayer Hlthcare · NDA 215341
Kerendia
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Jul 2035
Blocked by patent: US RE49826.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US RE49826 | drug substance · sets the listed date | 29 Jul 2035 |
| US 8436180 | drug substance, drug product | 26 Aug 2033 |
Exclusivities · 3 unexpired
| I-998 | new indication (3 years) | 16 Sep 2029 |
| NS | new strength | 11 Jul 2028 |
| I-970 | new indication (3 years) | 11 Jul 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic tentatively approved · ANDA 220684, Apotex Inc · 215341-001Tentative approval 27 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215341 · 001 · RLD | tablet, oral | 10MG | 29 Jul 2035 |
| 215341 · 002 · RLD | tablet, oral | 20MG | 29 Jul 2035 |
| 215341 · 003 · RLD | tablet, oral | 40MG | 29 Jul 2035 |
Expired or delisted (1)
- NCE · 9 Jul 2026