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 four patents protecting this drug. Additional details are available on the ZUNVEYL profile page.
The generic ingredient in ZUNVEYL is benzgalantamine gluconate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the benzgalantamine gluconate profile page.
The generic ingredient in ZUNVEYL is benzgalantamine gluconate. There is one drug master file entry for this compound. 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: | 4 |
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 | 84054-005-14 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-14) |
| 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) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 11,795,176 | Patent Expiration: | Jan 13, 2042 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE | ||||||||
| Patent: | 12,208,167 | Patent Expiration: | Feb 26, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE | ||||||||
| Patent: | 12,551,491 | Patent Expiration: | Jul 23, 2045 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE | ||||||||
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