Application 212099

Type: NDA
Sponsor: BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUBEQA	DAROLUTAMIDE	TABLET;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212099-001	NUBEQA	DAROLUTAMIDE	300MG	TABLET / ORAL		RLD, RS	2019-07-30

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11
N212099-001	11046713	2030-10-27		Drug substance	2021-07-28
N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27
N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27
N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27
N212099-001	10010530	2036-01-28		Drug substance	2019-08-27
N212099-001	10383853	2036-01-28		Drug substance	2019-08-27
N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11
N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27
N212099-001	12611397	2040-07-02		Drug product	2026-05-15
N212099-001	12329742	2042-06-17		Drug product	2025-07-02

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212099-001	I-971	2028-06-03

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 364 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10010530	2036-01-28		Drug substance	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10383853	2036-01-28		Drug substance	2019-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	12611397	2040-07-02		Drug product	2026-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212099-001	12329742	2042-06-17		Drug product	2025-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10010530	2036-01-28		Drug substance	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10383853	2036-01-28		Drug substance	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	12611397	2040-07-02		Drug product	2026-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212099-001	12329742	2042-06-17		Drug product	2025-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-02-18 07:12 UTC	2024-02	N212099-001	NCE	2024-07-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212099-001	I-900	2025-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212099-001	NCE	2024-07-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212099-001	I-900	2025-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212099-001	NCE	2024-07-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212099-001	I-900	2025-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212099-001	NCE	2024-07-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212099-001	I-900	2025-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212099-001	NCE	2024-07-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212099-001	I-900	2025-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212099-001	NCE	2024-07-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212099-001	I-900	2025-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212099-001	NCE	2024-07-30	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N212099-001	I-900	2025-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212099-001	NCE	2024-07-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N212099-001	I-900	2025-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212099-001	NCE	2024-07-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212099-001	I-900	2025-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212099-001	NCE	2024-07-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N212099-001	I-900	2025-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212099-001	NCE	2024-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212099-001	NCE	2024-07-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212099-001	I-971	2028-06-03	`a50c72e98297…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82460	SUPPL	2025-06-05
82466	SUPPL	2025-06-04
75780	SUPPL	2023-10-16
75732	SUPPL	2023-10-16
71775	SUPPL	2022-08-11
71739	SUPPL	2022-08-08
65873	SUPPL	2021-01-08
65871	SUPPL	2021-01-08
59870	ORIG	2019-08-29
59521	ORIG	2019-07-31
59518	ORIG	2019-07-31