Generic competition · all medicines · read 12 November 2026

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

Selpercatinib 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.

Selpercatinib2 dosage-form groups in the Orange Book

0generic makers listed

Selpercatinib 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.

Tablet, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

8 May 2027Exclusivity ODE* Retevmo
27 September 2027Exclusivity M-311 Retevmo
27 September 2027Exclusivity M-312 Retevmo
8 November 2027Exclusivity PED Retevmo
27 March 2028Exclusivity PED Retevmo
21 September 2029Exclusivity ODE* Retevmo
10 October 2037Patent 10172851
10 October 2037Patent 10137124
10 October 2037Patent 10112942 drug substance
10 April 2038Patent 10172851*PED
10 April 2038Patent 10137124*PED
10 April 2038Patent 10112942*PED
10 October 2038Patent 12138250
10 April 2039Patent 12138250*PED

Capsule, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

8 May 2027Exclusivity ODE-301 Retevmo
8 May 2027Exclusivity ODE-302 Retevmo
8 May 2027Exclusivity ODE-303 Retevmo
29 May 2027Exclusivity NPP Retevmo
27 September 2027Exclusivity M-311 Retevmo
27 September 2027Exclusivity M-312 Retevmo
10 October 2037Patent 10172851
10 October 2037Patent 10137124
10 October 2037Patent 10112942 drug substance
10 April 2038Patent 10112942*PED
10 April 2038Patent 10137124*PED
10 April 2038Patent 10172851*PED
10 October 2038Patent 12138250
10 October 2038Patent 10584124 drug substance

4 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.