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OmniRx › Tools › Generic competition check › Cobimetinib Fumarate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Cobimetinib Fumarate, and who makes it?

Cobimetinib Fumarate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Cobimetinib Fumarate1 dosage-form group in the Orange Book
0generic makers listed
  1. Cobimetinib Fumarate appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Cotellic. No generic is listed as marketed.

20152020202520302035204001brand 2015data datePatent 8362002*PED listed to expire 5 April 2027Patent 7803839 listed to expire 10 November 2029Patent 7803839*PED listed to expire 10 May 2030Patent 11087354 listed to expire 22 June 2034Patent 11087354*PED listed to expire 22 December 2034Patent 10478400 listed to expire 29 June 2036Patent 10590102 listed to expire 30 June 2036Patent 11254649 listed to expire 30 June 2036Patent 10478400*PED listed to expire 29 December 2036Patent 11254649*PED listed to expire 30 December 2036Patent 10590102*PED listed to expire 30 December 2036Exclusivity ODE-416 to 28 October 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 28 October 2029Exclusivity ODE-416 Cotellic
  • 5 April 2027Patent 8362002*PED
  • 10 November 2029Patent 7803839 drug substance
  • 10 May 2030Patent 7803839*PED
  • 22 June 2034Patent 11087354
  • 22 December 2034Patent 11087354*PED
  • 29 June 2036Patent 10478400 drug substance
  • 30 June 2036Patent 10590102 drug substance
  • 30 June 2036Patent 11254649 drug substance

3 more patents are listed.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.