Generic competition · all medicines · read 12 November 2026

Is there a generic of Ivacaftor; Lumacaftor, and who makes it?

Ivacaftor; Lumacaftor 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.

Ivacaftor; Lumacaftor2 dosage-form groups in the Orange Book

0generic makers listed

Ivacaftor; Lumacaftor 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.

Granule, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

13 December 2027Exclusivity M-14 Orkambi
13 June 2028Exclusivity PED Orkambi
2 September 2029Exclusivity ODE-408 Orkambi
2 March 2030Exclusivity PED Orkambi
28 December 2026Patent 9670163 drug product
28 December 2026Patent 9931334 drug product
28 December 2026Patent 8410274 drug product
28 December 2026Patent 8754224 drug substance
8 May 2027Patent 9216969*PED
8 May 2027Patent 7973038*PED
8 May 2027Patent 8741933*PED
20 May 2027Patent 7495103 drug substance

31 more patents are listed.

Tablet, Oral

Brand listed, no generic listed as marketed

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

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

Patents and exclusivities still listed

28 December 2026Patent 9931334 drug product
28 December 2026Patent 9670163 drug product
28 December 2026Patent 8754224 drug substance
28 December 2026Patent 8410274 drug product
8 May 2027Patent 9216969*PED
8 May 2027Patent 8741933*PED
8 May 2027Patent 7973038*PED
20 May 2027Patent 7495103 drug substance

35 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.