Generic competition · all medicines · read 12 November 2026
Is there a generic of Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor, and who makes it?
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor 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.
- Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor 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: Trikafta (Copackaged). No generic is listed as marketed.
Patents and exclusivities still listed
- 20 December 2027Exclusivity M-313 Trikafta (Copackaged)
- 26 April 2030Exclusivity ODE-433 Trikafta (Copackaged)
- 20 December 2031Exclusivity ODE-512 Trikafta (Copackaged)
- 27 March 2033Exclusivity ODE-543 Trikafta (Copackaged)
- 28 December 2026Patent 9931334 drug product
- 28 December 2026Patent 9670163 drug product
- 28 December 2026Patent 8410274 drug product
- 28 December 2026Patent 8754224 drug substance
- 9 April 2027Patent 9974781 drug product
- 9 April 2027Patent 11639347 drug substance
- 9 April 2027Patent 10239867 drug substance
- 9 April 2027Patent 10022352 drug product
25 more patents are listed.
Tablet, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Trikafta (Copackaged). No generic is listed as marketed.
Patents and exclusivities still listed
- 20 December 2027Exclusivity M-313 Trikafta (Copackaged)
- 21 December 2027Exclusivity ODE* Trikafta (Copackaged)
- 21 December 2027Exclusivity ODE-323 Trikafta (Copackaged)
- 8 June 2028Exclusivity ODE-357 Trikafta (Copackaged)
- 20 December 2031Exclusivity ODE-512 Trikafta (Copackaged)
- 27 March 2033Exclusivity ODE-543 Trikafta (Copackaged)
- 28 December 2026Patent 9931334 drug product
- 28 December 2026Patent 9670163 drug product
- 28 December 2026Patent 8410274 drug product
- 28 December 2026Patent 8754224 drug substance
- 9 April 2027Patent 11639347 drug substance
- 9 April 2027Patent 9974781 drug product
- 9 April 2027Patent 10022352 drug product
- 9 April 2027Patent 10239867 drug substance
21 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.