Application 215341

Type: NDA
Sponsor: BAYER HEALTHCARE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KERENDIA	FINERENONE	TABLET; ORAL	10MG	No	No
002	KERENDIA	FINERENONE	TABLET; ORAL	20MG	No	No
003	KERENDIA	FINERENONE	TABLET;ORAL	40MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215341-001	KERENDIA	FINERENONE	10MG	TABLET / ORAL	RLD	2021-07-09
N215341-002	KERENDIA	FINERENONE	20MG	TABLET / ORAL	RLD	2021-07-09
N215341-003	KERENDIA	FINERENONE	40MG	TABLET / ORAL	RLD, RS	2025-07-11

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06
N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01
N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06
N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01
N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25
N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215341-001	NCE	2026-07-09
N215341-001	I-970	2028-07-11
N215341-001	I-998	2029-09-16
N215341-002	NCE	2026-07-09
N215341-002	I-970	2028-07-11
N215341-002	I-998	2029-09-16
N215341-003	NCE	2026-07-09
N215341-003	NS	2028-07-11
N215341-003	I-998	2029-09-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 79 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD	2021-07-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD, RS	2025-07-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	8436180	2029-04-12	Drug substance, Drug product	2025-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	8436180	2029-04-12	Drug substance, Drug product	2025-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 151 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N215341-001	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	I-970	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-001	I-998	2029-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	I-970	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-002	I-998	2029-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	NCE	2026-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	NS	2028-07-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215341-003	I-998	2029-09-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215341-001	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-001	I-970	2028-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-002	I-970	2028-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	NCE	2026-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215341-003	NS	2028-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215341-001	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-001	I-970	2028-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-002	I-970	2028-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	NCE	2026-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215341-003	NS	2028-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215341-001	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-001	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NS	2028-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NS	2028-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	I-970	2028-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	NCE	2026-07-09	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82856	SUPPL	2026-05-12
82867	SUPPL	2025-07-15
72002	SUPPL	2022-09-02
71995	SUPPL	2022-09-02
68296	ORIG	2021-08-05
68048	ORIG	2021-07-12
68045	ORIG	2021-07-12