Cystic Fibrosis Therapeutics
1. Kalydeco patent expiration
Treatment: Treatment of cf in a patient age 1 month to less than 6 years old who has in the cftr gene at least one mutation responsive to iva based on clinical and/or in vitro assay data using the composition re...
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. | ||||
| US7495103 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 4 months from now) | |
| 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
(11 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
|
US8410274 (Pediatric) | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US8354427 (Pediatric) | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Jan, 2027
(11 months from now) | |
|
US8324242 (Pediatric) | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Feb, 2028
(2 years from now) | |
|
US8754224 (Pediatric) | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US8883206 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2033
(7 years from now) | |
|
US7495103 (Pediatric) | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Nov, 2027
(1 year, 10 months from now) | |
|
US9670163 (Pediatric) | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US10272046 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2033
(7 years from now) | |
|
US10646481 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2030
(4 years from now) | |
|
US11147770 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2033
(7 years from now) | |
|
US11752106 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2033
(7 years from now) | |
|
US12214083 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2033
(7 years from now) | |
|
US11564916 (Pediatric) | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2030
(4 years from now) | |
|
US12458635 (Pediatric) | VERTEX PHARMS INC | NA |
Feb, 2030
(4 years from now) | |
| US12458635 | VERTEX PHARMS INC | NA |
Aug, 2029
(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
(11 months from now) | |
| US8629162 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Jun, 2025
(6 months ago) | |
| US8354427 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Jul, 2026
(5 months from now) | |
| US11147770 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2033
(7 years from now) | |
| US11564916 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2029
(3 years from now) | |
| US12214083 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2033
(7 years from now) | |
| US8324242 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Aug, 2027
(1 year, 6 months from now) | |
| US10272046 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2033
(7 years from now) | |
| US11752106 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2033
(7 years from now) | |
| US8883206 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Feb, 2033
(7 years from now) | |
| US10646481 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2029
(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
(11 months from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 31, 2017 |
| New Indication(I-740) | Feb 21, 2017 |
| New Indication(I-705) | Dec 30, 2017 |
| Orphan Drug Exclusivity(ODE) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE-20) | Jan 31, 2019 |
| New Patient Population(NPP) | May 03, 2026 |
| Orphan Drug Exclusivity(ODE-186) | Feb 21, 2021 |
| Orphan Drug Exclusivity(ODE-187) | Dec 29, 2021 |
| Orphan Drug Exclusivity(ODE-188) | Mar 17, 2022 |
| Orphan Drug Exclusivity(ODE-190) | May 17, 2024 |
| Orphan Drug Exclusivity(ODE-189) | Jul 31, 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 |
| M(M-14) | May 22, 2028 |
| Pediatric Exclusivity(PED) | Nov 22, 2028 |
| Orphan Drug Exclusivity(ODE-435) | May 03, 2030 |
Drugs and Companies using IVACAFTOR ingredient
NCE-1 date: 23 November, 2027
Market Authorisation Date: 03 May, 2023
Dosage: GRANULE
How can I launch a generic of KALYDECO before it's drug patent expiration?
More Information on Dosage
KALYDECO family patents
2. Kalydeco patent expiration
Treatment: Method of treating cystic fibrosis; Treatment of cf in a patient age 6 years and older who has in the cftr gene at least one mutation respon...
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
(11 months from now) | |
| US7495103 | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
May, 2027
(1 year, 4 months from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US9670163 | VERTEX PHARMS | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(11 months from now) | |
| US12458635 | VERTEX PHARMS | NA |
Aug, 2029
(3 years from now) | |
| US8629162 | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Jun, 2025
(6 months ago) | |
| US11564916 | VERTEX PHARMS | Pharmaceutical composition and administrations thereof |
Aug, 2029
(3 years from now) | |
| US8324242 | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Aug, 2027
(1 year, 6 months from now) | |
| US8354427 | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Jul, 2026
(5 months 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
(11 months from now) | |
| US10646481 | VERTEX PHARMS | Pharmaceutical composition and administrations thereof |
Aug, 2029
(3 years from now) | |
|
US7495103 (Pediatric) | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Nov, 2027
(1 year, 10 months from now) | |
|
US8324242 (Pediatric) | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Feb, 2028
(2 years from now) | |
|
US8410274 (Pediatric) | VERTEX PHARMS | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US8754224 (Pediatric) | VERTEX PHARMS | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US8354427 (Pediatric) | VERTEX PHARMS | Modulators of ATP-binding cassette transporters |
Jan, 2027
(11 months from now) | |
|
US9670163 (Pediatric) | VERTEX PHARMS | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Jun, 2027
(1 year, 5 months from now) | |
|
US10646481 (Pediatric) | VERTEX PHARMS | Pharmaceutical composition and administrations thereof |
Feb, 2030
(4 years from now) | |
|
US12458635 (Pediatric) | VERTEX PHARMS | NA |
Feb, 2030
(4 years from now) | |
|
US11564916 (Pediatric) | VERTEX PHARMS | Pharmaceutical composition and administrations thereof |
Feb, 2030
(4 years from now) | |
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 31, 2017 |
| New Indication(I-740) | Feb 21, 2017 |
| New Indication(I-705) | Dec 30, 2017 |
| Orphan Drug Exclusivity(ODE) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE-20) | Jan 31, 2019 |
| New Patient Population(NPP) | May 03, 2026 |
| Orphan Drug Exclusivity(ODE-186) | Feb 21, 2021 |
| Orphan Drug Exclusivity(ODE-187) | Dec 29, 2021 |
| Orphan Drug Exclusivity(ODE-188) | Mar 17, 2022 |
| Orphan Drug Exclusivity(ODE-190) | May 17, 2024 |
| Orphan Drug Exclusivity(ODE-189) | Jul 31, 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 |
| M(M-14) | May 22, 2028 |
| Pediatric Exclusivity(PED) | Nov 22, 2028 |
| Orphan Drug Exclusivity(ODE-435) | May 03, 2030 |
Drugs and Companies using IVACAFTOR ingredient
NCE-1 date: 22 June, 2027
Market Authorisation Date: 20 May, 2019
Dosage: TABLET
How can I launch a generic of KALYDECO before it's drug patent expiration?
More Information on Dosage
KALYDECO family patents