Assyro AI

Orange Book product · Brand (NDA)

XCOPRI

CENOBAMATE

Brand (NDA)NDA 212839RX SK LIFE

At a glance

Mar 10, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 10, 2020

    6 yr 4 mo ago

  2. Today

  3. Patent 7598279 expires

    Listed drug substance patent expiration.

    Oct 30, 2032

    in 6 yr 6 mo

  4. Patent 11654133 expires

    Listed method-of-use patent (U-3610) expiration.

    Jun 16, 2039

    in 13 yr 2 mo

Pharmaceutical detail

Active ingredient

CENOBAMATE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 212839

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7598279Oct 30, 2032in 6 yr 6 mo
Substance
11654133Jun 16, 2039in 13 yr 2 mo
U-3610
Agent CTA Background

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