Assyro AI

Orange Book product · Brand (NDA)

ZUNVEYL

BENZGALANTAMINE GLUCONATE

Brand (NDA)NDA 218549RX ALPHA COGNITION

At a glance

Jul 26, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

4

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 2024

    1 yr 11 mo ago

  2. Today

  3. Patent 9763953 expires

    Listed method-of-use patent (U-713) expiration.

    Dec 01, 2026

    in 6 mo

  4. Patent 11795176 expires

    Listed drug substance patent expiration.

    Jan 13, 2042

    in 15 yr 10 mo

  5. Patent 12208167 expires

    Listed drug product patent expiration.

    Feb 26, 2044

    in 17 yr 11 mo

  6. Patent 12551491 expires

    Listed method-of-use patent (U-713) expiration.

    Jul 23, 2045

    in 19 yr 4 mo

Pharmaceutical detail

Active ingredient

BENZGALANTAMINE GLUCONATE

Strength

EQ 5MG BASE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 218549

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9763953Dec 01, 2026in 6 mo
U-713
11795176Jan 13, 2042in 15 yr 10 mo
SubstanceU-713
12208167Feb 26, 2044in 17 yr 11 mo
ProductU-713
12551491Jul 23, 2045in 19 yr 4 mo
U-713
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.