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OmniRx › Tools › Generic competition check › Ivacaftor

Generic competition · all medicines · read 12 November 2026

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

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.

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.
Ivacaftor2 dosage-form groups in the Orange Book
0generic makers listed
  1. 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. 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.
  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.

Granule, Oral

Brand listed, no generic listed as marketed

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

2015202020252030203501brand 2015data datePatent 9670163 listed to expire 28 December 2026Patent 8754224 listed to expire 28 December 2026Patent 8410274 listed to expire 28 December 2026Patent 8354427*PED listed to expire 6 January 2027Patent 7495103 listed to expire 20 May 2027Patent 9670163*PED listed to expire 28 June 2027Patent 8754224*PED listed to expire 28 June 2027Patent 8410274*PED listed to expire 28 June 2027Patent 8324242 listed to expire 5 August 2027Patent 7495103*PED listed to expire 20 November 2027Patent 8324242*PED listed to expire 5 February 2028Patent 11564916 listed to expire 13 August 2029Patent 12458635 listed to expire 13 August 2029Patent 10646481 listed to expire 13 August 2029Patent 11564916*PED listed to expire 13 February 2030Patent 10646481*PED listed to expire 13 February 2030Patent 12458635*PED listed to expire 13 February 2030Patent 11147770 listed to expire 27 February 2033Patent 10272046 listed to expire 27 February 2033Patent 12214083 listed to expire 27 February 2033Patent 11752106 listed to expire 27 February 2033Patent 8883206 listed to expire 27 February 2033Patent 11752106*PED listed to expire 27 August 2033Patent 12214083*PED listed to expire 27 August 2033Patent 11147770*PED listed to expire 27 August 2033Patent 10272046*PED listed to expire 27 August 2033Patent 8883206*PED listed to expire 27 August 2033Exclusivity ODE-338 to 21 December 2027Exclusivity M-14 to 22 May 2028Exclusivity PED to 21 June 2028Exclusivity PED to 22 November 2028Exclusivity ODE-435 to 3 May 2030Exclusivity PED to 3 November 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 December 2027Exclusivity ODE-338 Kalydeco
  • 22 May 2028Exclusivity M-14 Kalydeco
  • 21 June 2028Exclusivity PED Kalydeco
  • 22 November 2028Exclusivity PED Kalydeco
  • 3 May 2030Exclusivity ODE-435 Kalydeco
  • 3 November 2030Exclusivity PED Kalydeco
  • 28 December 2026Patent 9670163 drug product
  • 28 December 2026Patent 8754224 drug substance
  • 28 December 2026Patent 8410274 drug product
  • 6 January 2027Patent 8354427*PED
  • 20 May 2027Patent 7495103 drug substance
  • 28 June 2027Patent 9670163*PED
  • 28 June 2027Patent 8754224*PED
  • 28 June 2027Patent 8410274*PED

19 more patents are listed.

Tablet, Oral

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2012data datePatent 9670163 listed to expire 28 December 2026Patent 8410274 listed to expire 28 December 2026Patent 8754224 listed to expire 28 December 2026Patent 8354427*PED listed to expire 6 January 2027Patent 7495103 listed to expire 20 May 2027Patent 8410274*PED listed to expire 28 June 2027Patent 8754224*PED listed to expire 28 June 2027Patent 9670163*PED listed to expire 28 June 2027Patent 8324242 listed to expire 5 August 2027Patent 7495103*PED listed to expire 20 November 2027Patent 8324242*PED listed to expire 5 February 2028Patent 12458635 listed to expire 13 August 2029Patent 11564916 listed to expire 13 August 2029Patent 10646481 listed to expire 13 August 2029Patent 10646481*PED listed to expire 13 February 2030Patent 12458635*PED listed to expire 13 February 2030Patent 11564916*PED listed to expire 13 February 2030Exclusivity ODE-338 to 21 December 2027Exclusivity PED to 21 June 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 21 December 2027Exclusivity ODE-338 Kalydeco
  • 21 June 2028Exclusivity PED Kalydeco
  • 28 December 2026Patent 9670163 drug product
  • 28 December 2026Patent 8410274 drug product
  • 28 December 2026Patent 8754224 drug substance
  • 6 January 2027Patent 8354427*PED
  • 20 May 2027Patent 7495103 drug substance
  • 28 June 2027Patent 8410274*PED
  • 28 June 2027Patent 8754224*PED
  • 28 June 2027Patent 9670163*PED

9 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.