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 44.

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	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	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19
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	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	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19
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 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N212489-001	ONGENTYS	25MG	CAPSULE / ORAL	RLD	2020-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	ONGENTYS	50MG	CAPSULE / ORAL	RLD, RS	2020-04-24	`c2088c7a36db…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 866 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3870		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3871		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9550759	2026-07-26	U-3872		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8907099	2027-05-12		Drug substance	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8524746	2029-07-14	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	10071085	2030-03-31		Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	10583130	2030-03-31	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	12129247	2032-01-11	U-4038		2024-11-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-001	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3870		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3871		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9550759	2026-07-26	U-3872		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8907099	2027-05-12		Drug substance	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9745290	2027-10-10	U-3869	Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8524746	2029-07-14	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	10071085	2030-03-31		Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	10583130	2030-03-31	U-3869		2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	12129247	2032-01-11	U-4038		2024-11-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	8168793	2032-04-07	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N212489-002	9630955	2032-12-12	U-3869	Drug substance, Drug product	2020-05-19	`c2088c7a36db…`
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…`

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…`

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