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OmniRx › Tools › Generic competition check › Mirdametinib

Generic competition · all medicines · read 12 November 2026

Is there a generic of Mirdametinib, and who makes it?

Mirdametinib appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 2 groups have 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.
Mirdametinib2 dosage-form groups in the Orange Book
0generic makers listed
  1. Mirdametinib appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 2 groups have 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, For Suspension, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2025data datePatent 12357597 listed to expire 17 February 2041Patent 12090128 listed to expire 17 February 2041Patent 12037306 listed to expire 17 February 2041Patent 11806321 listed to expire 17 February 2041Patent 12263146 listed to expire 17 February 2041Patent 11453641 listed to expire 17 February 2041Patent 12011424 listed to expire 17 February 2041Patent 12295925 listed to expire 17 February 2041Patent 11819487 listed to expire 17 February 2041Patent 11084780 listed to expire 17 February 2041Patent 11571402 listed to expire 17 February 2041Patent 11066358 listed to expire 17 February 2041Patent 12220390 listed to expire 16 March 2043Patent 11883375 listed to expire 16 March 2043Patent 11839595 listed to expire 16 March 2043Patent 12257215 listed to expire 16 March 2043Patent 12324791 listed to expire 16 March 2043Patent 11806322 listed to expire 9 April 2043Patent 12661330 listed to expire 5 February 2044Patent 12029711 listed to expire 15 March 2044Patent 12390430 listed to expire 10 October 2044Exclusivity NCE to 11 February 2030Exclusivity ODE-488 to 11 February 2032Exclusivity ODE* to 11 February 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 11 February 2030Exclusivity NCE Gomekli
  • 11 February 2032Exclusivity ODE-488 Gomekli
  • 11 February 2032Exclusivity ODE* Gomekli
  • 17 February 2041Patent 12357597
  • 17 February 2041Patent 12090128 drug product
  • 17 February 2041Patent 12037306
  • 17 February 2041Patent 11806321
  • 17 February 2041Patent 12263146
  • 17 February 2041Patent 11453641
  • 17 February 2041Patent 12011424
  • 17 February 2041Patent 12295925

13 more patents are listed.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2025data datePatent 11806321 listed to expire 17 February 2041Patent 11453641 listed to expire 17 February 2041Patent 12263146 listed to expire 17 February 2041Patent 12275688 listed to expire 17 February 2041Patent 12037306 listed to expire 17 February 2041Patent 12295925 listed to expire 17 February 2041Patent 12011424 listed to expire 17 February 2041Patent 11819487 listed to expire 17 February 2041Patent 11066358 listed to expire 17 February 2041Patent 11084780 listed to expire 17 February 2041Patent 11883375 listed to expire 16 March 2043Patent 11839595 listed to expire 16 March 2043Patent 12257215 listed to expire 16 March 2043Patent 12220390 listed to expire 16 March 2043Patent 12324791 listed to expire 16 March 2043Patent 11806322 listed to expire 9 April 2043Patent 12661330 listed to expire 5 February 2044Patent 12383517 listed to expire 15 March 2044Patent 12029711 listed to expire 15 March 2044Patent 12390430 listed to expire 10 October 2044Exclusivity NCE to 11 February 2030Exclusivity ODE-488 to 11 February 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 11 February 2030Exclusivity NCE Gomekli
  • 11 February 2032Exclusivity ODE-488 Gomekli
  • 17 February 2041Patent 11806321
  • 17 February 2041Patent 11453641
  • 17 February 2041Patent 12263146
  • 17 February 2041Patent 12275688 drug product
  • 17 February 2041Patent 12037306
  • 17 February 2041Patent 12295925
  • 17 February 2041Patent 12011424
  • 17 February 2041Patent 11819487

12 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.