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
(3 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, 1 month 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) | |
| US11564916 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2029
(5 years from now) | |
| US10646481 | 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) | |
| US11147770 | 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) | |
| 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 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 cf in a patient age 1 month to <4 months who has at least 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 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 1 month to <4 months 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 10272046, treatment of cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has 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 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, treatment of cf in a patient age 1 month to <4 months 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 11147770, 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 responsive to ivacaftor based on clinical and/or in vitro assay data.
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 |
Drugs and Companies using
IVACAFTOR ingredient
NCE-1 date:
Market Authorisation Date:
03 May, 2023Treatment:
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 responsive to ivacaftor based on clinical and/or in vitro assay da...Dosage:
How can I launch a generic of KALYDECO before its drug patent expiration?
More Information on Dosage
KALYDECO 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 | 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
(3 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, 1 month 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 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, 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.
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 |
Drugs and Companies using
IVACAFTOR ingredient
NCE-1 date:
Market Authorisation Date:
20 May, 2019Treatment:
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:
How can I launch a generic of KALYDECO before its drug patent expiration?
More Information on Dosage
KALYDECO family patents