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Kalydeco patents expiration

KALYDECO's oppositions filed in EPO

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug 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

(2 years from now)

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

(2 years from now)

These drug 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

(1 year, 8 days from now)

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

(2 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

(2 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

(2 years from now)

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

(3 years from now)

US11564916 VERTEX PHARMS Pharmaceutical composition and administrations thereof
Aug, 2029

(5 years from now)

US10646481 VERTEX PHARMS Pharmaceutical composition and administrations thereof
Aug, 2029

(5 years from now)

Kalydeco is owned by Vertex Pharms.

Kalydeco contains Ivacaftor.

Kalydeco has a total of 9 drug patents out of which 0 drug patents have expired.

Kalydeco was authorised for market use on 20 May, 2019.

Kalydeco is available in tablet;oral dosage forms.

Kalydeco can be used as 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 cf in a patient age 6 years and older 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 11564916, 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.

Drug patent challenges can be filed against Kalydeco from 01 February, 2016.

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

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-189) Jul 31, 2024
Orphan Drug Exclusivity(ODE-190) May 17, 2024
Orphan Drug Exclusivity(ODE-199) Aug 15, 2025
Orphan Drug Exclusivity(ODE-338) Dec 21, 2027
New Indication(I-705) Dec 30, 2017
Orphan Drug Exclusivity(ODE-187) Dec 29, 2021
Orphan Drug Exclusivity(ODE-186) Feb 21, 2021
New Indication(I-740) Feb 21, 2017
New Patient Population(NPP) Jul 31, 2020
Orphan Drug Exclusivity(ODE-20) Jan 31, 2019
Orphan Drug Exclusivity(ODE) Jan 31, 2019
New Chemical Entity Exclusivity(NCE) Jan 31, 2017

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Drugs and Companies using IVACAFTOR ingredient

NCE-1 date:

01 February, 2016

Market Authorisation Date:

20 May, 2019

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 ...

Dosage:

TABLET;ORAL

How can I launch a generic of KALYDECO before its drug patent expiration?

More Information on Dosage

KALYDECO family patents

Family Patents

KALYDECO's oppositions filed in EPO

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug 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

(2 years from now)

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

(2 years from now)

These drug 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

(1 year, 8 days from now)

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

(2 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

(2 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

(2 years from now)

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

(3 years from now)

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

(5 years from now)

US11564916 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Aug, 2029

(5 years from now)

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

(8 years from now)

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

(8 years from now)

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

(8 years from now)

US11752106 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(8 years from now)

Kalydeco is owned by Vertex Pharms Inc.

Kalydeco contains Ivacaftor.

Kalydeco has a total of 13 drug patents out of which 0 drug patents have expired.

Kalydeco was authorised for market use on 03 May, 2023.

Kalydeco is available in granule;oral dosage forms.

Kalydeco can be used as 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 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 11564916, 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 cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has a r117h mutation in the cftr gene, 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 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 1 month to <6 years who has at least 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 11752106.

Drug patent challenges can be filed against Kalydeco from 01 February, 2016.

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

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-189) Jul 31, 2024
Orphan Drug Exclusivity(ODE-190) May 17, 2024
Orphan Drug Exclusivity(ODE-199) Aug 15, 2025
Orphan Drug Exclusivity(ODE-236) Apr 29, 2026
Orphan Drug Exclusivity(ODE-338) Dec 21, 2027
Orphan Drug Exclusivity(ODE-435) May 03, 2030
New Patient Population(NPP) Apr 29, 2022
New Indication(I-740) Feb 21, 2017
Orphan Drug Exclusivity(ODE) Jan 31, 2019
New Chemical Entity Exclusivity(NCE) Jan 31, 2017
Orphan Drug Exclusivity(ODE-20) Jan 31, 2019
Orphan Drug Exclusivity(ODE-188) Mar 17, 2022

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Drugs and Companies using IVACAFTOR ingredient

NCE-1 date:

01 February, 2016

Market Authorisation Date:

03 May, 2023

Treatment:

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...

Dosage:

GRANULE;ORAL

How can I launch a generic of KALYDECO before its drug patent expiration?

More Information on Dosage

KALYDECO family patents

Family Patents