Application 218549

Type: NDA
Sponsor: ALPHA COGNITION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZUNVEYL	BENZGALANTAMINE GLUCONATE	TABLET, DELAYED RELEASE;ORAL	EQ 5MG BASE	Yes	Yes
002	ZUNVEYL	BENZGALANTAMINE GLUCONATE	TABLET, DELAYED RELEASE;ORAL	EQ 10MG BASE	Yes	No
003	ZUNVEYL	BENZGALANTAMINE GLUCONATE	TABLET, DELAYED RELEASE;ORAL	EQ 15MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218549-001	ZUNVEYL	BENZGALANTAMINE GLUCONATE	EQ 5MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2024-07-26
N218549-002	ZUNVEYL	BENZGALANTAMINE GLUCONATE	EQ 10MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26
N218549-003	ZUNVEYL	BENZGALANTAMINE GLUCONATE	EQ 15MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218549-001	9763953	2026-12-01	U-713		2024-08-22
N218549-001	11795176	2042-01-13	U-713	Drug substance	2024-08-22
N218549-001	12208167	2044-02-26	U-713	Drug product	2025-02-20
N218549-001	12551491	2045-07-23	U-713		2026-02-20
N218549-002	9763953	2026-12-01	U-713		2024-08-22
N218549-002	11795176	2042-01-13	U-713	Drug substance	2024-08-22
N218549-002	12208167	2044-02-26	U-713	Drug product	2025-02-20
N218549-002	12551491	2045-07-23	U-713		2026-02-20
N218549-003	9763953	2026-12-01	U-713		2024-08-22
N218549-003	11795176	2042-01-13	U-713	Drug substance	2024-08-22
N218549-003	12208167	2044-02-26	U-713	Drug product	2025-02-20
N218549-003	12551491	2045-07-23	U-713		2026-02-20

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 2 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218549-002	ZUNVEYL	EQ 10MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218549-003	ZUNVEYL	EQ 15MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218549-001	ZUNVEYL	EQ 5MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2024-07-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218549-002	ZUNVEYL	EQ 10MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218549-003	ZUNVEYL	EQ 15MG BASE	TABLET, DELAYED RELEASE / ORAL	RLD	2024-07-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 120 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	N218549-001	9763953	2026-12-01	U-713		2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-001	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-001	12208167	2044-02-26	U-713	Drug product	2025-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-001	12551491	2045-07-23	U-713		2026-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-002	9763953	2026-12-01	U-713		2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-002	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-002	12208167	2044-02-26	U-713	Drug product	2025-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-002	12551491	2045-07-23	U-713		2026-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-003	9763953	2026-12-01	U-713		2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-003	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-003	12208167	2044-02-26	U-713	Drug product	2025-02-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218549-003	12551491	2045-07-23	U-713		2026-02-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218549-001	9763953	2026-12-01	U-713		2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-001	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-001	12208167	2044-02-26	U-713	Drug product	2025-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-001	12551491	2045-07-23	U-713		2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-002	9763953	2026-12-01	U-713		2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-002	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-002	12208167	2044-02-26	U-713	Drug product	2025-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-002	12551491	2045-07-23	U-713		2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-003	9763953	2026-12-01	U-713		2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-003	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-003	12208167	2044-02-26	U-713	Drug product	2025-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218549-003	12551491	2045-07-23	U-713		2026-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218549-001	9763953	2026-12-01	U-713		2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-001	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-001	12208167	2044-02-26	U-713	Drug product	2025-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-001	12551491	2045-07-23	U-713		2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-002	9763953	2026-12-01	U-713		2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-002	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-002	12208167	2044-02-26	U-713	Drug product	2025-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-002	12551491	2045-07-23	U-713		2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-003	9763953	2026-12-01	U-713		2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-003	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-003	12208167	2044-02-26	U-713	Drug product	2025-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218549-003	12551491	2045-07-23	U-713		2026-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218549-001	9763953	2026-12-01	U-713		2024-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218549-001	11795176	2042-01-13	U-713	Drug substance	2024-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218549-001	12208167	2044-02-26	U-713	Drug product	2025-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218549-002	9763953	2026-12-01	U-713		2024-08-22	`011fe1cb6892…`

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
82473	ORIG	2025-06-06
82475	ORIG	2024-07-26
82474	ORIG	2024-07-26