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Generic competition · all medicines · read 12 November 2026

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

Monomethyl 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.
Monomethyl Fumarate1 dosage-form group in the Orange Book
0generic makers listed
  1. Monomethyl 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.

Capsule, Delayed Release, Oral

Brand listed, no generic listed as marketed

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

202020252030203501brand 2020data datePatent 11903918 listed to expire 27 February 2035Patent 10918615 listed to expire 27 February 2035Patent 10918616 listed to expire 27 February 2035Patent 11590095 listed to expire 27 February 2035Patent 9511043 listed to expire 27 February 2035Patent 9326965 listed to expire 27 February 2035Patent 9814692 listed to expire 27 February 2035Patent 9636318 listed to expire 27 February 2035Patent 9814691 listed to expire 27 February 2035Patent 10105336 listed to expire 27 February 2035Patent 9820961 listed to expire 27 February 2035Patent 10098863 listed to expire 27 February 2035Patent 9517209 listed to expire 27 February 2035Patent 9566259 listed to expire 27 February 2035Patent 9326947 listed to expire 27 February 2035Patent 10105335 listed to expire 27 February 2035Patent 10105337 listed to expire 27 February 2035Patent 10918617 listed to expire 27 February 2035Patent 9636319 listed to expire 27 February 2035Patent 10945985 listed to expire 27 February 2035Patent 9820960 listed to expire 27 February 2035
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 27 February 2035Patent 11903918
  • 27 February 2035Patent 10918615 drug product
  • 27 February 2035Patent 10918616
  • 27 February 2035Patent 11590095
  • 27 February 2035Patent 9511043
  • 27 February 2035Patent 9326965
  • 27 February 2035Patent 9814692
  • 27 February 2035Patent 9636318

13 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.