Question 1

Is there a generic for Benzgalantamine gluconate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Benzgalantamine gluconate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Benzgalantamine gluconate?

Accepted Answer

ZUNVEYL (NDA 218549, ALPHA COGNITION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Benzgalantamine gluconate?

Accepted Answer

The Orange Book lists 4 patents against Benzgalantamine gluconate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Benzgalantamine gluconate are approved?

Accepted Answer

Benzgalantamine gluconate is approved in the following dosage form: tablet, delayed release.

Patent	Expires	In	Type
9763953	Dec 01, 2026	in 6 mo	U-713
11795176	Jan 13, 2042	in 15 yr 10 mo	SubstanceU-713
12208167	Feb 26, 2044	in 17 yr 11 mo	ProductU-713
12551491	Jul 23, 2045	in 19 yr 4 mo	U-713

Benzgalantamine gluconate

Brand (NDA) products · tablet, delayed release

Listed patents (4)

Benzgalantamine gluconate — frequently asked questions

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