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FDA Orange Book · active-ingredient family

Cobimetinib fumarate

Cobimetinib fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:COTELLIC · NDA 206192

1

Brand (NDA)

0

Generics (ANDA)

13

Listed patents

3

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
COTELLICRLDGENENTECH INCNDA 206192—Nov 10, 2015

Marketing exclusivity (3)

  • M-278New use / labeling-change exclusivity (3 years)

    Jul 28, 2025

    11 mo ago

  • ODE-416Orphan-drug exclusivity (7 years)

    Oct 28, 2029

    in 3 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    Jan 28, 2026

    5 mo ago

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8362002Oct 05, 2026in 4 mo
U-1776
11597699Oct 05, 2026in 4 mo
U-3554
8362002*PEDApr 05, 2027in 10 mo
7803839Nov 10, 2029in 3 yr 5 mo
SubstanceProduct
7803839*PEDMay 10, 2030in 3 yr 11 mo
11087354Jun 22, 2034in 8 yr 2 mo
U-1776
11087354*PEDDec 22, 2034in 8 yr 8 mo
10478400Jun 29, 2036in 10 yr 2 mo
SubstanceProductU-1776
10590102Jun 30, 2036in 10 yr 2 mo
SubstanceProductU-1776
11254649Jun 30, 2036in 10 yr 2 mo
SubstanceProductU-1776
10478400*PEDDec 29, 2036in 10 yr 8 mo
11254649*PEDDec 30, 2036in 10 yr 8 mo
10590102*PEDDec 30, 2036in 10 yr 8 mo

Cobimetinib fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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