Generic competition · all medicines · read 12 November 2026

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

Trofinetide 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.

Trofinetide2 dosage-form groups in the Orange Book

0generic makers listed

Trofinetide 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.
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.

For Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Daybue Stix. No generic is listed as marketed.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

10 March 2028Exclusivity NCE Daybue Stix
10 September 2028Exclusivity PED Daybue Stix
10 March 2030Exclusivity ODE* Daybue Stix
10 September 2030Exclusivity PED Daybue Stix
27 January 2032Patent 9212204
27 July 2032Patent 9212204*PED
3 August 2040Patent 11370755 drug substance
3 February 2041Patent 11370755*PED
12 July 2042Patent 12492167 drug substance
12 July 2042Patent 11827600 drug substance
12 January 2043Patent 12492167*PED
12 January 2043Patent 11827600*PED

Solution, Oral

Brand listed, no generic listed as marketed

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

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

10 March 2028Exclusivity NCE Daybue
10 September 2028Exclusivity PED Daybue
10 March 2030Exclusivity ODE-425 Daybue
10 September 2030Exclusivity PED Daybue
27 January 2032Patent 9212204
27 July 2032Patent 9212204*PED
3 August 2040Patent 11370755 drug substance
3 February 2041Patent 11370755*PED
12 July 2042Patent 12492167 drug substance
12 July 2042Patent 11827600 drug substance
12 January 2043Patent 11827600*PED
12 January 2043Patent 12492167*PED

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.