Pharsight

1. List of Kalydeco drug patents

Patent Number	Company	Patent Title	Patent Expiry
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

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

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
150 mg	10 Jun, 2020	1		13 Aug, 2029
25 mg, 50 mg and 75 mg	13 Apr, 2022	1		27 Feb, 2033

Strength	Dosage	Availability
150MG	TABLET;ORAL	Prescription

2. List of Kalydeco drug patents

Patent Number	Company	Patent Title	Patent Expiry
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

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