Application 212489

Type: NDA
Sponsor: NEUROCRINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONGENTYS	OPICAPONE	CAPSULE;ORAL	25MG	No	No
002	ONGENTYS	OPICAPONE	CAPSULE;ORAL	50MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212489-001	ONGENTYS	OPICAPONE	25MG	CAPSULE / ORAL		RLD	2020-04-24
N212489-002	ONGENTYS	OPICAPONE	50MG	CAPSULE / ORAL		RLD, RS	2020-04-24

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212489-001	9550759	2026-07-26	U-3870		2020-05-19
N212489-001	9550759	2026-07-26	U-3871		2020-05-19
N212489-001	9550759	2026-07-26	U-3872		2020-05-19
N212489-001	8907099	2027-05-12		Drug substance	2020-05-19
N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19
N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19
N212489-001	8524746	2029-07-14	U-3869		2020-05-19
N212489-001	10071085	2030-03-31		Drug product	2020-05-19
N212489-001	10583130	2030-03-31	U-3869		2020-05-19
N212489-001	12129247	2032-01-11	U-4038		2024-11-26
N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19
N212489-002	9550759	2026-07-26	U-3870		2020-05-19
N212489-002	9550759	2026-07-26	U-3871		2020-05-19
N212489-002	9550759	2026-07-26	U-3872		2020-05-19
N212489-002	8907099	2027-05-12		Drug substance	2020-05-19
N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19
N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19
N212489-002	8524746	2029-07-14	U-3869		2020-05-19
N212489-002	10071085	2030-03-31		Drug product	2020-05-19
N212489-002	10583130	2030-03-31	U-3869		2020-05-19
N212489-002	12129247	2032-01-11	U-4038		2024-11-26
N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19

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 · 78 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	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 844 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	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	10071085	2030-03-31		Drug product	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	10583130	2030-03-31	U-3869		2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	12129247	2032-01-11	U-4038		2024-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8168793	2027-10-10	U-3869	Drug substance, Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-001	NCE	2025-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212489-002	NCE	2025-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212489-001	NCE	2025-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212489-002	NCE	2025-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-001	NCE	2025-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212489-002	NCE	2025-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-001	NCE	2025-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212489-002	NCE	2025-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-001	NCE	2025-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212489-002	NCE	2025-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-001	NCE	2025-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212489-002	NCE	2025-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-001	NCE	2025-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212489-002	NCE	2025-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-001	NCE	2025-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212489-002	NCE	2025-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212489-001	NCE	2025-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212489-002	NCE	2025-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-001	NCE	2025-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212489-002	NCE	2025-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-001	NCE	2025-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212489-002	NCE	2025-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-001	NCE	2025-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212489-002	NCE	2025-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212489-001	NCE	2025-04-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212489-002	NCE	2025-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-001	NCE	2025-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212489-002	NCE	2025-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212489-001	NCE	2025-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212489-002	NCE	2025-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212489-001	NCE	2025-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212489-002	NCE	2025-04-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212489-001	NCE	2025-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212489-002	NCE	2025-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212489-001	NCE	2025-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212489-002	NCE	2025-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212489-001	NCE	2025-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212489-002	NCE	2025-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212489-001	NCE	2025-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212489-002	NCE	2025-04-24	`5aa47cf7b7d7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONGENTYS	OPICAPONE	Amneal Pharmaceuticals LLC	a511a531-112e-43f8-a43f-5334b0efe979	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212489 application number: NDA212489

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70370-3025	ONGENTYS	opicapone	Neurocrine Biosciences, Inc.	NDA	Current
70370-3050	ONGENTYS	opicapone	Neurocrine Biosciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83755	SUPPL	2025-10-15
83744	SUPPL	2025-10-14
81215	SUPPL	2025-02-11
81180	SUPPL	2025-02-10
63296	ORIG	2020-05-26
62701	ORIG	2020-04-28
62680	ORIG	2020-04-27