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OmniRx › Tools › Generic competition check › Fenfluramine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Fenfluramine Hydrochloride, and who makes it?

Fenfluramine Hydrochloride 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.
Fenfluramine Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Fenfluramine Hydrochloride 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.

Solution, Oral

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2020data datePatent 9603815 listed to expire 3 May 2033Patent 9549909 listed to expire 3 May 2033Patent 9610260 listed to expire 3 May 2033Patent 9603814 listed to expire 3 May 2033Patent 10478442 listed to expire 3 May 2033Patent 10478441 listed to expire 3 May 2033Patent 12097206 listed to expire 3 May 2033Patent 9603815*PED listed to expire 3 November 2033Patent 9549909*PED listed to expire 3 November 2033Patent 9610260*PED listed to expire 3 November 2033Patent 9603814*PED listed to expire 3 November 2033Patent 10478442*PED listed to expire 3 November 2033Patent 10478441*PED listed to expire 3 November 2033Patent 12097206*PED listed to expire 3 November 2033Patent 10947183 listed to expire 20 December 2036Patent 10947183*PED listed to expire 20 June 2037Patent 10603290 listed to expire 2 August 2037Patent 11759440 listed to expire 2 August 2037Patent 11040018 listed to expire 2 August 2037Patent 11406606 listed to expire 2 August 2037Patent 11786487 listed to expire 2 August 2037Patent 11759440*PED listed to expire 2 February 2038Patent 11406606*PED listed to expire 2 February 2038Patent 10603290*PED listed to expire 2 February 2038Patent 11040018*PED listed to expire 2 February 2038Patent 11786487*PED listed to expire 2 February 2038Patent 10452815*PED listed to expire 29 December 2038Exclusivity ODE-312 to 25 June 2027Exclusivity PED to 25 December 2027Exclusivity ODE-393 to 25 March 2029Exclusivity PED to 25 September 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 25 June 2027Exclusivity ODE-312 Fintepla
  • 25 December 2027Exclusivity PED Fintepla
  • 25 March 2029Exclusivity ODE-393 Fintepla
  • 25 September 2029Exclusivity PED Fintepla
  • 3 May 2033Patent 9603815
  • 3 May 2033Patent 9549909
  • 3 May 2033Patent 9610260
  • 3 May 2033Patent 9603814
  • 3 May 2033Patent 10478442
  • 3 May 2033Patent 10478441
  • 3 May 2033Patent 12097206
  • 3 November 2033Patent 9603815*PED

19 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.