Details for New Drug Application (NDA): 215341
NDA 215341 describes KERENDIA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the KERENDIA profile page.
The generic ingredient in KERENDIA is finerenone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the finerenone profile page.
The generic ingredient in KERENDIA is finerenone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the finerenone profile page.
Summary for 215341
| Tradename: | KERENDIA |
| Applicant: | Bayer Hlthcare |
| Ingredient: | finerenone |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215341
Generic Entry Date for 215341*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215341
| Mechanism of Action | Mineralocorticoid Receptor Antagonists |
Suppliers and Packaging for NDA: 215341
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KERENDIA | finerenone | TABLET;ORAL | 215341 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-540 | 50419-540-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01) |
| KERENDIA | finerenone | TABLET;ORAL | 215341 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-540 | 50419-540-02 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 9, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 9, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 11, 2028 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, HOSPITALIZATION FOR HEART FAILURE, AND URGENT HEART FAILURE VISITS IN ADULT PATIENTS WITH HEART FAILURE WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF) >= 40% | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2029 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE URINARY ALBUMIN-TO-CREATININE RATIO, WHICH IS EXPECTED TO REDUCE THE RISK OF SUSTAINED ESTIMATED GLOMERULAR FILTRATION RATE DECLINE AND END-STAGE KIDNEY DISEASE IN ADULTS WITH CHRONIC KIDNEY DISEASE ASSOCIATED WITH TYPE 1 DIABETES MELLITUS | ||||||||
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