List of Kalydeco drug patents

Kalydeco is owned by Vertex Pharms.

Kalydeco contains Ivacaftor.

Kalydeco has a total of 8 drug patents out of which 0 drug patents have expired.

Kalydeco was authorised for market use on 31 January, 2012.

Kalydeco is available in tablet;oral dosage forms.

Kalydeco can be used as method of treating a patient having cystic fibrosis, the patient having a r117h mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; method of treating cystic fibrosis, method of treating cystic fibrosis; method of treating a patient having cystic fibrosis, such as a patient having a g551d mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide, use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate cf phenotype with at least one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data, method of treating cystic fibrosis.

The generics of Kalydeco are possible to be released after 13 August, 2029.

Patent Number Company Patent Title Patent Expiry Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8754224 VERTEX PHARMS Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US7495103 VERTEX PHARMS Modulators of ATP-binding cassette transporters
May, 2027

(4 years from now)

These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8629162 VERTEX PHARMS Modulators of ATP-binding cassette transporters
Jun, 2025

(2 years from now)

US8354427 VERTEX PHARMS Modulators of ATP-binding cassette transporters
Jul, 2026

(3 years from now)

US9670163 VERTEX PHARMS Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US8410274 VERTEX PHARMS Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US8324242 VERTEX PHARMS Modulators of ATP-binding cassette transporters
Aug, 2027

(4 years from now)

US10646481 VERTEX PHARMS Pharmaceutical composition and administrations thereof
Aug, 2029

(6 years from now)

Exclusivity Exclusivity Expiration
Orphan Drug Exclusivity (ODE) Dec 21, 2027

Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 31 January, 2012

Treatment: Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate cf phenotype with at least one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; Method of treating cystic fibrosis; Method of treating a patient having cystic fibrosis, such as a patient having a g551d mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide

Dosage: TABLET;ORAL

How can I launch a generic of KALYDECO before it's patent expiration?
More Information on Dosage

Kalydeco is owned by Vertex Pharms Inc.

Kalydeco contains Ivacaftor.

Kalydeco has a total of 11 drug patents out of which 0 drug patents have expired.

Kalydeco was authorised for market use on 17 March, 2015.

Kalydeco is available in granule;oral dosage forms.

Kalydeco can be used as method of treating a patient having cystic fibrosis, such as a patient having a g551d mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; method of treating cystic fibrosis; treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data, treatment of a moderate mild clinical phenotype of cf using ivacaftor in a patient age 6 months to <6 years who has one cftr mutation repsonsive to ivacaftor based on clinical and/or in vitro assay data; use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate cf phenotype with at least one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; treatment of a moderate to mild clinical phenotype of cf using ivacaftor in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data, treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11147770, method of treating cystic fibrosis; treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has a r117h mutation in the cftr gene; method of treating a patient having cystic fibrosis, the patient having a r117h mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has a r117h mutation in the cftr gene, method of treating cystic fibrosis; treatment of cf in a patient age 6 months to < 6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor; treatment of cf in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor, treatment of cf in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046; treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046.

The generics of Kalydeco are possible to be released after 27 February, 2033.

Patent Number Company Patent Title Patent Expiry Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8754224 VERTEX PHARMS INC Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US7495103 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(4 years from now)

These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8629162 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2025

(2 years from now)

US8354427 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jul, 2026

(3 years from now)

US8410274 VERTEX PHARMS INC Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US9670163 VERTEX PHARMS INC Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(3 years from now)

US8324242 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Aug, 2027

(4 years from now)

US10646481 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Aug, 2029

(6 years from now)

US8883206 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(10 years from now)

US11147770 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(10 years from now)

US10272046 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(10 years from now)

Exclusivity Exclusivity Expiration
Orphan Drug Exclusivity (ODE) Dec 21, 2027
New Patient Population (NPP) Apr 29, 2022

Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 17 March, 2015

Treatment: Treatment of a moderate mild clinical phenotype of cf using ivacaftor in a patient age 6 months to <6 years who has one cftr mutation repsonsive to ivacaftor based on clinical and/or in vitro assay data; Use of ivacaftor for treating cystic fibrosis in a patient with a mild to moderate cf phenotype with at least one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of a moderate to mild clinical phenotype of cf using ivacaftor in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data; Method of treating cystic fibrosis; Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has a r117h mutation in the cftr gene; Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has a r117h mutation in the cftr gene; Treatment of cf in a patient age 6 months to < 6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor; Treatment of cf in a patient age 4 months to <6 years who has one cftr mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor; Method of treating a patient having cystic fibrosis, such as a patient having a g551d mutation in cftr, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide; Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data; Treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11147770; Treatment of cf in a patient age 6 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046; Treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 10272046

Dosage: GRANULE;ORAL

How can I launch a generic of KALYDECO before it's patent expiration?
More Information on Dosage

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