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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 218549


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NDA 218549 describes ZUNVEYL, which is a drug marketed by Alpha Cognition and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZUNVEYL profile page.

The generic ingredient in ZUNVEYL is benzgalantamine gluconate. One supplier is listed for this compound. Additional details are available on the benzgalantamine gluconate profile page.
Summary for 218549
Tradename:ZUNVEYL
Applicant:Alpha Cognition
Ingredient:benzgalantamine gluconate
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218549
Generic Entry Date for 218549*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 218549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZUNVEYL benzgalantamine gluconate TABLET, DELAYED RELEASE;ORAL 218549 NDA Alpha Cognition, Inc. 84054-005 84054-005-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-60)
ZUNVEYL benzgalantamine gluconate TABLET, DELAYED RELEASE;ORAL 218549 NDA Alpha Cognition, Inc. 84054-010 84054-010-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-010-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 5MG BASE
Approval Date:Jul 26, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 13, 2042Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE
Patent:⤷  Sign UpPatent Expiration:May 16, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 10MG BASE
Approval Date:Jul 26, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 13, 2042Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE

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