Application 213969

Type: NDA
Sponsor: EIGER BIOPHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOKINVY	LONAFARNIB	CAPSULE;ORAL	50MG	Yes	No
002	ZOKINVY	LONAFARNIB	CAPSULE;ORAL	75MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N213969-001	ZOKINVY	LONAFARNIB	50MG	CAPSULE / ORAL		RLD	2020-11-20
N213969-002	ZOKINVY	LONAFARNIB	75MG	CAPSULE / ORAL		RLD, RS	2020-11-20

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213969-001	7838531	2029-07-26	U-3070		2021-02-24
N213969-002	7838531	2029-07-26	U-3070		2021-02-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213969-001	ODE-324	2027-11-20
N213969-002	ODE-324	2027-11-20

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 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213969-001	ZOKINVY	50MG	CAPSULE / ORAL	RLD	2020-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213969-002	ZOKINVY	75MG	CAPSULE / ORAL	RLD, RS	2020-11-20	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213969-001	7838531	2029-07-26	U-3070	2021-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213969-002	7838531	2029-07-26	U-3070	2021-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-001	7838531	2029-07-26	U-3070	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-002	7838531	2029-07-26	U-3070	2021-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-001	7838531	2029-07-26	U-3070	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-002	7838531	2029-07-26	U-3070	2021-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-001	7838531	2024-07-26	U-3070	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-001	8828356	2024-10-17	U-3070	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-002	7838531	2024-07-26	U-3070	2021-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-002	8828356	2024-10-17	U-3070	2021-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213969-001	7838531	2025-07-26	U-3070	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-001	8828356	2025-10-17	U-3070	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-002	7838531	2025-07-26	U-3070	2021-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-002	8828356	2025-10-17	U-3070	2021-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-001	7838531	2024-07-26	U-3070	2021-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-001	8828356	2024-10-17	U-3070	2021-02-24	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 134 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213969-001	ODE-324	2027-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213969-002	ODE-324	2027-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-001	NCE	2025-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-001	ODE-324	2027-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-002	NCE	2025-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213969-002	ODE-324	2027-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213969-001	NCE	2025-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-001	ODE-324	2027-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-002	NCE	2025-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213969-002	ODE-324	2027-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-001	NCE	2025-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-001	ODE-324	2027-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-002	NCE	2025-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213969-002	ODE-324	2027-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-001	NCE	2025-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-001	ODE-324	2027-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-002	NCE	2025-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213969-002	ODE-324	2027-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-001	NCE	2025-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-001	ODE-324	2027-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-002	NCE	2025-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213969-002	ODE-324	2027-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-001	NCE	2025-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-001	ODE-324	2027-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-002	NCE	2025-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213969-002	ODE-324	2027-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-001	NCE	2025-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-001	ODE-324	2027-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-002	NCE	2025-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213969-002	ODE-324	2027-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-001	NCE	2025-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-001	ODE-324	2027-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-002	NCE	2025-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213969-002	ODE-324	2027-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213969-001	NCE	2025-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-001	ODE-324	2027-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-002	NCE	2025-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213969-002	ODE-324	2027-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-001	NCE	2025-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213969-001	ODE-324	2027-11-20	`79d66fd596c7…`

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
Zokinvy	LONAFARNIB	Sentynl Therapeutics, Inc.	97391d0c-943e-4c5a-8423-68e163aa7f50	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213969 application number: NDA213969

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73079-050	Zokinvy	lonafarnib	Eiger BioPharmaceuticals, Inc.	NDA	Current
73079-050	Lonafarnib	lonafarnib	Eiger BioPharmaceuticals, Inc.	NDA	Current
73079-075	Zokinvy	lonafarnib	Eiger BioPharmaceuticals, Inc.	NDA	Current
73079-075	Lonafarnib	lonafarnib	Eiger BioPharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77930	SUPPL	2024-03-25
77929	SUPPL	2024-03-25
77919	SUPPL	2024-03-22
77918	SUPPL	2024-03-22
65697	ORIG	2020-12-23
65625	ORIG	2020-12-18
65320	ORIG	2020-11-25