Ivacaftor Patent Expiration

Ivacaftor is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment. It was first introduced by Vertex Pharmaceuticals Inc in its drug Kalydeco on Jan 31, 2012. 2 different companies have introduced drugs containing Ivacaftor.


Ivacaftor Patents

Given below is the list of patents protecting Ivacaftor, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Kalydeco US10272046

(Pediatric)

Pharmaceutical composition and administrations thereof Aug 27, 2033 Vertex Pharms Inc
Kalydeco US11147770

(Pediatric)

Pharmaceutical composition and administrations thereof Aug 27, 2033 Vertex Pharms Inc
Kalydeco US11752106

(Pediatric)

Pharmaceutical composition and administrations thereof Aug 27, 2033 Vertex Pharms Inc
Kalydeco US12214083

(Pediatric)

Pharmaceutical composition and administrations thereof Aug 27, 2033 Vertex Pharms Inc
Kalydeco US8883206

(Pediatric)

Pharmaceutical composition and administrations thereof Aug 27, 2033 Vertex Pharms Inc
Kalydeco US10272046 Pharmaceutical composition and administrations thereof Feb 27, 2033 Vertex Pharms Inc
Kalydeco US11147770 Pharmaceutical composition and administrations thereof Feb 27, 2033 Vertex Pharms Inc
Kalydeco US11752106 Pharmaceutical composition and administrations thereof Feb 27, 2033 Vertex Pharms Inc
Kalydeco US12214083 Pharmaceutical composition and administrations thereof Feb 27, 2033 Vertex Pharms Inc
Kalydeco US8883206 Pharmaceutical composition and administrations thereof Feb 27, 2033 Vertex Pharms Inc
Kalydeco US10646481

(Pediatric)

Pharmaceutical composition and administrations thereof Feb 13, 2030 Vertex Pharms
Kalydeco US10646481

(Pediatric)

Pharmaceutical composition and administrations thereof Feb 13, 2030 Vertex Pharms Inc
Kalydeco US11564916

(Pediatric)

Pharmaceutical composition and administrations thereof Feb 13, 2030 Vertex Pharms
Kalydeco US11564916

(Pediatric)

Pharmaceutical composition and administrations thereof Feb 13, 2030 Vertex Pharms Inc
Kalydeco US12458635

(Pediatric)

Pharmaceutical Composition And Administrations Thereof Feb 13, 2030 Vertex Pharms
Kalydeco US12458635

(Pediatric)

Pharmaceutical Composition And Administrations Thereof Feb 13, 2030 Vertex Pharms Inc
Kalydeco US10646481 Pharmaceutical composition and administrations thereof Aug 13, 2029 Vertex Pharms
Kalydeco US10646481 Pharmaceutical composition and administrations thereof Aug 13, 2029 Vertex Pharms Inc
Kalydeco US11564916 Pharmaceutical composition and administrations thereof Aug 13, 2029 Vertex Pharms
Kalydeco US11564916 Pharmaceutical composition and administrations thereof Aug 13, 2029 Vertex Pharms Inc
Kalydeco US12458635 Pharmaceutical Composition And Administrations Thereof Aug 13, 2029 Vertex Pharms
Kalydeco US12458635 Pharmaceutical Composition And Administrations Thereof Aug 13, 2029 Vertex Pharms Inc
Kalydeco US8324242

(Pediatric)

Modulators of ATP-binding cassette transporters Feb 05, 2028 Vertex Pharms
Kalydeco US8324242

(Pediatric)

Modulators of ATP-binding cassette transporters Feb 05, 2028 Vertex Pharms Inc
Kalydeco US7495103

(Pediatric)

Modulators of ATP-binding cassette transporters Nov 20, 2027 Vertex Pharms
Kalydeco US7495103

(Pediatric)

Modulators of ATP-binding cassette transporters Nov 20, 2027 Vertex Pharms Inc
Kalydeco US8324242 Modulators of ATP-binding cassette transporters Aug 05, 2027 Vertex Pharms
Kalydeco US8324242 Modulators of ATP-binding cassette transporters Aug 05, 2027 Vertex Pharms Inc
Kalydeco US8410274

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms
Kalydeco US8410274

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms Inc
Kalydeco US8754224

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms
Kalydeco US8754224

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms Inc
Kalydeco US9670163

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms
Kalydeco US9670163

(Pediatric)

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Jun 28, 2027 Vertex Pharms Inc
Kalydeco US7495103 Modulators of ATP-binding cassette transporters May 20, 2027 Vertex Pharms
Kalydeco US7495103 Modulators of ATP-binding cassette transporters May 20, 2027 Vertex Pharms Inc
Kalydeco US8354427

(Pediatric)

Modulators of ATP-binding cassette transporters Jan 06, 2027 Vertex Pharms
Kalydeco US8354427

(Pediatric)

Modulators of ATP-binding cassette transporters Jan 06, 2027 Vertex Pharms Inc
Kalydeco US8410274 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms
Kalydeco US8410274 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms Inc
Kalydeco US8754224 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms
Kalydeco US8754224 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms Inc
Kalydeco US9670163 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms
Kalydeco US9670163 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Dec 28, 2026 Vertex Pharms Inc
Kalydeco US8354427 Modulators of ATP-binding cassette transporters Jul 06, 2026

(Expired)

Vertex Pharms
Kalydeco US8354427 Modulators of ATP-binding cassette transporters Jul 06, 2026

(Expired)

Vertex Pharms Inc
Kalydeco US8629162 Modulators of ATP-binding cassette transporters Jun 24, 2025

(Expired)

Vertex Pharms
Kalydeco US8629162 Modulators of ATP-binding cassette transporters Jun 24, 2025

(Expired)

Vertex Pharms Inc



Ivacaftor's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Ivacaftor:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Vertex Pharmaceuticals Incorporated NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) Vertex Pharmaceuticals Incorporated NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants Vertex Pharmaceuticals Incorporated NA RECRUITING
(Sep 1, 2026)
PHASE1
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Vertex Pharmaceuticals Incorporated NA RECRUITING
(Sep 1, 2026)
PHASE1
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF ReCode Therapeutics NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Trikafta in Cystic Fibrosis Patients Emory University NA COMPLETED
(Jul 1, 2026)
PHASE2
Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients Qanatpharma AG NA RECRUITING
(Jul 1, 2026)
PHASE2
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older Vertex Pharmaceuticals Incorporated NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Vertex Pharmaceuticals Incorporated NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Vertex Pharmaceuticals Incorporated NA ENROLLING BY INVITATION
(Apr 1, 2026)
PHASE3


Ivacaftor Generic API Manufacturers

Given below is the list of companies who have filed for Ivacaftor generic, along with the locations of their manufacturing plants worldwide.


Ivacaftor News

US Expenditure on High-Value Medications for Rare Diseases in 2022 | AJMC

15 Nov, 2025

Supporters and patient organizations establish a collective purchasing group for a generic medication for cystic fibrosis.

24 Oct, 2025

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