Application 215211

Type: NDA
Sponsor: AMICUS THERAP US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPFOLDA	MIGLUSTAT	CAPSULE;ORAL	65MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N215211-001	OPFOLDA	MIGLUSTAT	65MG	CAPSULE / ORAL		RLD, RS	2023-09-28

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215211-001	10512677	2033-03-07	U-3726		2023-10-26
N215211-001	11278599	2033-03-07	U-3726		2023-10-26
N215211-001	12419937	2033-03-07	U-3726		2025-10-21
N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26
N215211-001	10961522	2035-09-30	U-3726		2023-10-26
N215211-001	11753632	2035-09-30	U-3726		2023-10-26
N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26
N215211-001	12414985	2036-12-29	U-3726		2025-10-21
N215211-001	10857212	2037-08-12	U-3726		2023-10-26
N215211-001	12246062	2038-09-16	U-3726		2025-03-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215211-001	NP	2026-09-28

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
2026-08-18 06:07:40	2026-07	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL	RLD, RS	2023-09-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	12419937	2033-03-07	U-3726		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	10961522	2035-09-30	U-3726		2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	11753632	2035-09-30	U-3726		2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	12414985	2036-12-29	U-3726		2025-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	10857212	2037-08-12	U-3726		2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215211-001	12246062	2038-09-16	U-3726		2025-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	12419937	2033-03-07	U-3726		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	10961522	2035-09-30	U-3726		2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	11753632	2035-09-30	U-3726		2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	12414985	2036-12-29	U-3726		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	10857212	2037-08-12	U-3726		2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215211-001	12246062	2038-09-16	U-3726		2025-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	12419937	2033-03-07	U-3726		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	10961522	2035-09-30	U-3726		2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	11753632	2035-09-30	U-3726		2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	12414985	2036-12-29	U-3726		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	10857212	2037-08-12	U-3726		2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	12246062	2038-09-16	U-3726		2025-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	10961522	2035-09-30	U-3726		2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	11753632	2035-09-30	U-3726		2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	10857212	2037-08-12	U-3726		2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215211-001	12246062	2038-09-16	U-3726		2025-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215211-001	NP	2026-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215211-001	NP	2026-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215211-001	NP	2026-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215211-001	NP	2026-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215211-001	NP	2026-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215211-001	NP	2026-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215211-001	NP	2026-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215211-001	NP	2026-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215211-001	NP	2026-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215211-001	NP	2026-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215211-001	NP	2026-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215211-001	NP	2026-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215211-001	NP	2026-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215211-001	NP	2026-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215211-001	NP	2026-09-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215211-001	NP	2026-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215211-001	NP	2026-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215211-001	NP	2026-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215211-001	NP	2026-09-28	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215211-001	NP	2026-09-28	`a50c72e98297…`

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
OPFOLDA	MIGLUSTAT	AMICUS THERAPEUTICS US, LLC	d7c38298-37db-5a80-e053-2995a90aee40	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215211 application number: NDA215211

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79239	SUPPL	2024-07-29
79217	SUPPL	2024-07-26
75990	ORIG	2023-10-31
75620	ORIG	2023-09-29
75601	ORIG	2023-09-28