Assyro AI

Orange Book product · Brand (NDA)

ERIVEDGE

VISMODEGIB

Brand (NDA)NDA 203388RX GENENTECH

At a glance

Jan 30, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 2012

    14 yr 7 mo ago

  2. Today

  3. Patent 7888364 expires

    Listed drug substance patent expiration.

    Nov 11, 2028

    in 2 yr 5 mo

  4. Patent 9278961 expires

    Listed method-of-use patent (U-1825) expiration.

    Dec 15, 2028

    in 2 yr 6 mo

Pharmaceutical detail

Active ingredient

VISMODEGIB

Strength

150MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 203388

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
7888364Nov 11, 2028in 2 yr 5 mo
SubstanceProduct
9278961Dec 15, 2028in 2 yr 6 mo
U-1825
Agent CTA Background

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