Assyro AI

Orange Book product · Brand (NDA)

ZELBORAF

VEMURAFENIB

Brand (NDA)NDA 202429RX HOFFMANN LA ROCHE

At a glance

Aug 17, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 17, 2011

    15 yr 1 mo ago

  2. Today

  3. Patent 8143271 expires

    Listed drug substance patent expiration.

    Jun 21, 2026

    in 2 d

  4. Patent 8470818 expires

    Listed method-of-use patent (U-2164) expiration.

    Aug 02, 2026

    in 1 mo

  5. Patent 8470818 expires

    Listed method-of-use patent (U-1418) expiration.

    Aug 02, 2026

    in 1 mo

  6. Patent 7504509 expires

    Listed drug substance patent expiration.

    Oct 22, 2026

    in 4 mo

  7. Patent 7863288 expires

    Listed drug substance patent expiration.

    Jun 20, 2029

    in 3 yr 1 mo

  8. Patent 8741920 expires

    Listed drug substance patent expiration.

    Jul 27, 2030

    in 4 yr 2 mo

  9. Patent 9447089 expires

    Listed drug product patent expiration.

    Jun 06, 2032

    in 6 yr 1 mo

Pharmaceutical detail

Active ingredient

VEMURAFENIB

Strength

240MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 202429

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 (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8143271Jun 21, 2026in 2 d
SubstanceProduct
8470818Aug 02, 2026in 1 mo
U-2164
8470818Aug 02, 2026in 1 mo
U-1418
7504509Oct 22, 2026in 4 mo
SubstanceProduct
7863288Jun 20, 2029in 3 yr 1 mo
SubstanceProduct
8741920Jul 27, 2030in 4 yr 2 mo
SubstanceProduct
9447089Jun 06, 2032in 6 yr 1 mo
Product
Agent CTA Background

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