Vertex Pharmaceuticals

Kalydeco (ivacaftor)

Active

Oral CFTR potentiator for cystic fibrosis. Vertex's U.S. prescriber page says Kalydeco is indicated for patients 1 month and older who have at least one CFTR mutation responsive to ivacaftor potentiation based on clinical and/or in vitro data. It remains a commercial medicine. The Q3 2026 earnings table groups it with Orkambi and Symdeko/Symkevi in other CF product revenue of $130.5 million.

Latest update Nov 5, 2026

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Current status

Still listed on Vertex's U.S. approved-medicines page. Q3 2026 sales are inside other CF revenue of $130.5 million and are not reported alone.

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Specifications1

Q3 2026 revenue
Not reported separately
  1. Vertex withdraws EU filings for toddler CF drugs

    The European Medicines Agency said on September 18 that Vertex Pharmaceuticals (Ireland) Limited had withdrawn applications to extend Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) to children aged one year and older with cystic fibrosis, used together as a combination regimen. The notice came in the CHMP highlights from the committee's September 14-17 meeting, which listed the pair among three already-authorised medicines whose indication-extension filings were pulled. Existing EU approvals for older patients are not themselves revoked by the withdrawals.

    European Medicines Agency

  2. Court clears Lupin's generic Kalydeco in Vertex patent fight

    A Delaware federal court ruled on August 24 that Lupin's proposed generic version of Vertex's cystic fibrosis drug Kalydeco does not infringe Vertex's patents, finding Lupin's 74% ivacaftor formulation falls outside the patents' claimed 80% concentration range. The ruling clears a path for Lupin, which already holds tentative FDA approval, to launch the first generic challenger to a Vertex CF modulator pending final FDA approval.

    Katten Muchin Rosenman Bloomberg Law

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