Application 217759

Type: NDA
Sponsor: PHARMING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JOENJA	LENIOLISIB PHOSPHATE	TABLET;ORAL	EQ 70MG BASE	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
N217759-001	JOENJA	LENIOLISIB PHOSPHATE	EQ 70MG BASE	TABLET / ORAL		RLD, RS	2023-03-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217759-001	8653092	2032-02-19		Drug substance, Drug product	2023-04-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217759-001	NCE	2028-03-24
N217759-001	ODE-430	2030-03-24

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.

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	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217759-001	JOENJA	EQ 70MG BASE	TABLET / ORAL	RLD, RS	2023-03-24	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217759-001	8653092	2032-02-19	Drug substance, Drug product	2023-04-18	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217759-001	NCE	2028-03-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217759-001	ODE-430	2030-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217759-001	NCE	2028-03-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217759-001	ODE-430	2030-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217759-001	NCE	2028-03-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217759-001	ODE-430	2030-03-24	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217759-001	NCE	2028-03-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217759-001	ODE-430	2030-03-24	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82394	SUPPL	2025-06-02
82351	SUPPL	2025-05-29
74034	ORIG	2023-04-21
73873	ORIG	2023-03-27
73863	ORIG	2023-03-24