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OmniRx › Tools › Generic competition check › Ivacaftor; Ivacaftor, Tezacaftor

Generic competition · all medicines · read 12 November 2026

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

Ivacaftor; Ivacaftor, Tezacaftor 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.
Ivacaftor; Ivacaftor, Tezacaftor1 dosage-form group in the Orange Book
0generic makers listed
  1. Ivacaftor; Ivacaftor, Tezacaftor 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: Symdeko (Copackaged). No generic is listed as marketed.

2015202020252030203501brand 2018data datePatent 9670163 listed to expire 28 December 2026Patent 9931334 listed to expire 28 December 2026Patent 8410274 listed to expire 28 December 2026Patent 8754224 listed to expire 28 December 2026Patent 10239867 listed to expire 9 April 2027Patent 10022352 listed to expire 9 April 2027Patent 11639347 listed to expire 9 April 2027Patent 9974781 listed to expire 9 April 2027Patent 8598181 listed to expire 1 May 2027Patent 7645789 listed to expire 1 May 2027Patent 8623905 listed to expire 1 May 2027Patent 7495103 listed to expire 20 May 2027Patent 7776905 listed to expire 3 June 2027Patent 8324242 listed to expire 5 August 2027Patent 8415387 listed to expire 12 November 2027Patent 12458635 listed to expire 13 August 2029Patent 11564916 listed to expire 13 August 2029Patent 10646481 listed to expire 13 August 2029Patent 11578062 listed to expire 25 March 2031Patent 10081621 listed to expire 25 March 2031Patent RE50453 listed to expire 10 July 2031Patent 10058546 listed to expire 15 July 2033Patent 9012496 listed to expire 15 July 2033Patent 10206877 listed to expire 14 April 2035Patent 11951212 listed to expire 14 April 2035Exclusivity ODE-335 to 21 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 December 2027Exclusivity ODE-335 Symdeko (Copackaged)
  • 28 December 2026Patent 9670163 drug product
  • 28 December 2026Patent 9931334 drug product
  • 28 December 2026Patent 8410274 drug product
  • 28 December 2026Patent 8754224 drug substance
  • 9 April 2027Patent 10239867 drug substance
  • 9 April 2027Patent 10022352 drug product
  • 9 April 2027Patent 11639347 drug substance
  • 9 April 2027Patent 9974781 drug product

17 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.