Is there a generic for Cobimetinib fumarate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cobimetinib fumarate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Cobimetinib fumarate?

COTELLIC (NDA 206192, GENENTECH INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Cobimetinib fumarate?

The Orange Book lists 13 patents against Cobimetinib fumarate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Cobimetinib fumarate have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Cobimetinib fumarate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Cobimetinib fumarate are approved?

Cobimetinib fumarate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Cobimetinib fumarate

Cobimetinib fumarate: 1 brand, 0 generics; first approved Nov 10, 2015; on patent until Oct 05, 2026.

On patent3 exclusivity periods

Generic status & protection

Protected until Oct 05, 2026 (earliest listed patent expiry).

Earliest patent expiry Oct 05, 2026Latest exclusivity ends Oct 28, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 05, 2026

in 3 mo

Originator applications

Brand (NDA) products

COTELLICRLDRS

GENENTECH INCNDA 2061922015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (3)

M-278New use / labeling-change exclusivity (3 years)
Jul 28, 2025
1 yr ago
ODE-416Orphan-drug exclusivity (7 years)
Oct 28, 2029
in 3 yr 4 mo
PEDPediatric exclusivity (adds 6 months)
Jan 28, 2026
6 mo ago

Orange Book patent file

Listed patents

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8362002	Oct 05, 2026	in 3 mo	U-1776
11597699	Oct 05, 2026	in 3 mo	U-3554
8362002*PED	Apr 05, 2027	in 9 mo
7803839	Nov 10, 2029	in 3 yr 5 mo	SubstanceProduct
7803839*PED	May 10, 2030	in 3 yr 11 mo
11087354	Jun 22, 2034	in 8 yr 1 mo	U-1776
11087354*PED	Dec 22, 2034	in 8 yr 7 mo
10478400	Jun 29, 2036	in 10 yr 1 mo	SubstanceProductU-1776
10590102	Jun 30, 2036	in 10 yr 1 mo	SubstanceProductU-1776
11254649	Jun 30, 2036	in 10 yr 1 mo	SubstanceProductU-1776
10478400*PED	Dec 29, 2036	in 10 yr 7 mo
11254649*PED	Dec 30, 2036	in 10 yr 7 mo
10590102*PED	Dec 30, 2036	in 10 yr 7 mo

FDA approval span

Approval history

First approval

Nov 10, 2015

10 yr 10 mo ago

Most recent approval

Nov 10, 2015

10 yr 10 mo ago

All 1 application were approved in 2015.

Brand (NDA) 1100%

Generic (ANDA) 00%

Cobimetinib fumarate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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