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OmniRx › Tools › Generic competition check › Mitapivat Sulfate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Mitapivat Sulfate, and who makes it?

Mitapivat Sulfate 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.
Mitapivat Sulfate1 dosage-form group in the Orange Book
0generic makers listed
  1. Mitapivat Sulfate 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: Aqvesme and Pyrukynd. No generic is listed as marketed.

20202025203020352040204501brand 2022data datePatent 10632114 listed to expire 3 May 2032Patent 9682080 listed to expire 3 May 2032Patent 9980961 listed to expire 3 May 2032Patent 9193701 listed to expire 26 October 2032Patent 11793806 listed to expire 12 April 2033Patent RE49582 listed to expire 11 April 2035Patent 11234976 listed to expire 11 October 2038Patent 11254652 listed to expire 21 November 2038Patent 11878049 listed to expire 31 July 2041Exclusivity NCE to 17 February 2027Exclusivity NP to 23 December 2028Exclusivity ODE-392 to 17 February 2029Exclusivity ODE-522 to 23 December 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 17 February 2027Exclusivity NCE Aqvesme
  • 23 December 2028Exclusivity NP Aqvesme
  • 17 February 2029Exclusivity ODE-392 Pyrukynd
  • 23 December 2032Exclusivity ODE-522 Aqvesme
  • 3 May 2032Patent 10632114
  • 3 May 2032Patent 9682080
  • 3 May 2032Patent 9980961
  • 26 October 2032Patent 9193701
  • 12 April 2033Patent 11793806
  • 11 April 2035Patent RE49582 drug substance
  • 11 October 2038Patent 11234976
  • 21 November 2038Patent 11254652 drug substance

1 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.