Application 215559

Type: NDA
Sponsor: IPSEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOHONOS	PALOVAROTENE	CAPSULE;ORAL	1MG	Yes	No
002	SOHONOS	PALOVAROTENE	CAPSULE;ORAL	1.5MG	Yes	No
003	SOHONOS	PALOVAROTENE	CAPSULE;ORAL	2.5MG	Yes	No
004	SOHONOS	PALOVAROTENE	CAPSULE;ORAL	5MG	Yes	No
005	SOHONOS	PALOVAROTENE	CAPSULE;ORAL	10MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215559-001	SOHONOS	PALOVAROTENE	1MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-002	SOHONOS	PALOVAROTENE	1.5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-003	SOHONOS	PALOVAROTENE	2.5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-004	SOHONOS	PALOVAROTENE	5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-005	SOHONOS	PALOVAROTENE	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N215559-001	10292954	2031-08-31	U-3676	2023-09-07
N215559-001	12023312	2031-08-31	U-3966	2024-07-25
N215559-001	9314439	2031-08-31	U-3676	2023-09-07
N215559-001	9789074	2031-08-31	U-3676	2023-09-07
N215559-001	10864194	2037-06-08	U-3676	2023-09-07
N215559-001	11622959	2037-06-08	U-3676	2023-09-07
N215559-001	12138245	2037-06-08	U-4031	2024-11-15
N215559-001	12201614	2037-06-08	U-4031	2025-02-07
N215559-001	12458626	2037-06-08	U-3676	2025-12-03
N215559-002	10292954	2031-08-31	U-3676	2023-09-07
N215559-002	12023312	2031-08-31	U-3966	2024-07-25
N215559-002	9314439	2031-08-31	U-3676	2023-09-07
N215559-002	9789074	2031-08-31	U-3676	2023-09-07
N215559-002	10864194	2037-06-08	U-3676	2023-09-07
N215559-002	11622959	2037-06-08	U-3676	2023-09-07
N215559-002	12138245	2037-06-08	U-4031	2024-11-15
N215559-002	12201614	2037-06-08	U-4031	2025-02-07
N215559-002	12458626	2037-06-08	U-3676	2025-12-03
N215559-003	10292954	2031-08-31	U-3676	2023-09-07
N215559-003	12023312	2031-08-31	U-3966	2024-07-25
N215559-003	9314439	2031-08-31	U-3676	2023-09-07
N215559-003	9789074	2031-08-31	U-3676	2023-09-07
N215559-003	10864194	2037-06-08	U-3676	2023-09-07
N215559-003	11622959	2037-06-08	U-3676	2023-09-07
N215559-003	12138245	2037-06-08	U-4031	2024-11-15
N215559-003	12201614	2037-06-08	U-4031	2025-02-07
N215559-003	12458626	2037-06-08	U-3676	2025-12-03
N215559-004	10292954	2031-08-31	U-3676	2023-09-07
N215559-004	12023312	2031-08-31	U-3966	2024-07-25
N215559-004	9314439	2031-08-31	U-3676	2023-09-07
N215559-004	9789074	2031-08-31	U-3676	2023-09-07
N215559-004	10864194	2037-06-08	U-3676	2023-09-07
N215559-004	11622959	2037-06-08	U-3676	2023-09-07
N215559-004	12138245	2037-06-08	U-4031	2024-11-15
N215559-004	12201614	2037-06-08	U-4031	2025-02-07
N215559-004	12458626	2037-06-08	U-3676	2025-12-03
N215559-005	10292954	2031-08-31	U-3676	2023-09-07
N215559-005	12023312	2031-08-31	U-3966	2024-07-25
N215559-005	9314439	2031-08-31	U-3676	2023-09-07
N215559-005	9789074	2031-08-31	U-3676	2023-09-07
N215559-005	10864194	2037-06-08	U-3676	2023-09-07
N215559-005	11622959	2037-06-08	U-3676	2023-09-07
N215559-005	12138245	2037-06-08	U-4031	2024-11-15
N215559-005	12201614	2037-06-08	U-4031	2025-02-07
N215559-005	12458626	2037-06-08	U-3676	2025-12-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215559-001	NCE	2028-08-16
N215559-001	ODE-439	2030-08-16
N215559-002	NCE	2028-08-16
N215559-002	ODE-439	2030-08-16
N215559-003	NCE	2028-08-16
N215559-003	ODE-439	2030-08-16
N215559-004	NCE	2028-08-16
N215559-004	ODE-439	2030-08-16
N215559-005	NCE	2028-08-16
N215559-005	ODE-439	2030-08-16

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 3 · 110 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	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 730 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215559-001	10292954	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	12023312	2031-08-31	U-3966	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	9314439	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	9789074	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	10864194	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	11622959	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	12138245	2037-06-08	U-4031	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	12201614	2037-06-08	U-4031	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-001	12458626	2037-06-08	U-3676	2025-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	10292954	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	12023312	2031-08-31	U-3966	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	9314439	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	9789074	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	10864194	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	11622959	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	12138245	2037-06-08	U-4031	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	12201614	2037-06-08	U-4031	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	12458626	2037-06-08	U-3676	2025-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	10292954	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	12023312	2031-08-31	U-3966	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	9314439	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	9789074	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	10864194	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	11622959	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	12138245	2037-06-08	U-4031	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	12201614	2037-06-08	U-4031	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	12458626	2037-06-08	U-3676	2025-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	10292954	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	12023312	2031-08-31	U-3966	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	9314439	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	9789074	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	10864194	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	11622959	2037-06-08	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	12138245	2037-06-08	U-4031	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	12201614	2037-06-08	U-4031	2025-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	12458626	2037-06-08	U-3676	2025-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	10292954	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	12023312	2031-08-31	U-3966	2024-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	9314439	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	9789074	2031-08-31	U-3676	2023-09-07	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 6 of 6 · 220 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	N215559-001	NCE	2028-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-001	ODE-439	2030-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-002	NCE	2028-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-002	ODE-439	2030-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-003	NCE	2028-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-003	ODE-439	2030-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-004	NCE	2028-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-004	ODE-439	2030-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-005	NCE	2028-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215559-005	ODE-439	2030-08-16	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-001	NCE	2028-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-001	ODE-439	2030-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-002	NCE	2028-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-002	ODE-439	2030-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-003	NCE	2028-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-003	ODE-439	2030-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-004	NCE	2028-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-004	ODE-439	2030-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-005	NCE	2028-08-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215559-005	ODE-439	2030-08-16	`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
81607	SUPPL	2025-03-17
81596	SUPPL	2025-03-17
81595	SUPPL	2025-03-17
75489	ORIG	2023-09-15
75111	ORIG	2023-08-17
75108	ORIG	2023-08-17