Elexacaftor, ivacaftor, tezacaftor; ivacaftor - Generic Drug Details
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What are the generic sources for elexacaftor, ivacaftor, tezacaftor; ivacaftor and what is the scope of freedom to operate?
Elexacaftor, ivacaftor, tezacaftor; ivacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elexacaftor, ivacaftor, tezacaftor; ivacaftor has four hundred and ninety-four patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor
International Patents: | 494 |
US Patents: | 32 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 21 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for elexacaftor, ivacaftor, tezacaftor; ivacaftor |
DailyMed Link: | elexacaftor, ivacaftor, tezacaftor; ivacaftor at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elexacaftor, ivacaftor, tezacaftor; ivacaftor
Generic Entry Dates for elexacaftor, ivacaftor, tezacaftor; ivacaftor*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, TABLET;ORAL |
Generic Entry Dates for elexacaftor, ivacaftor, tezacaftor; ivacaftor*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULES;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for elexacaftor, ivacaftor, tezacaftor; ivacaftor
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chiesi USA, Inc. | Phase 4 |
University of North Carolina, Chapel Hill | Phase 4 |
Emory University | Phase 4 |
See all elexacaftor, ivacaftor, tezacaftor; ivacaftor clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for elexacaftor, ivacaftor, tezacaftor; ivacaftor
US Patents and Regulatory Information for elexacaftor, ivacaftor, tezacaftor; ivacaftor
International Patents for elexacaftor, ivacaftor, tezacaftor; ivacaftor
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2532650 | Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) | ⤷ Try a Trial |
European Patent Office | 2464337 | Formulation en tablette du N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide pour utilisation pour le traitement de la muscovisidose (Tablet formulation of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide for use in the treatment of cystic fibrosis) | ⤷ Try a Trial |
China | 111818918 | 用于治疗囊性纤维化的药物组合物 (PHARMACEUTICAL COMPOSITIONS FOR TREATING CYSTIC FIBROSIS) | ⤷ Try a Trial |
Japan | 2014156468 | MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS | ⤷ Try a Trial |
Ukraine | 102261 | ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ОСНОВІ ТВЕРДОЇ ДИСПЕРСІЇ N-[2,4-БІС(1,1-ДИМЕТИЛЕТИЛ)-5-ГІДРОКСИФЕНІЛ]-1,4-ДИГІДРО-4-ОКСОХІНОЛІН-3-КАРБОКСАМІДУ[ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИЯ НА ОСНОВЕ ТВЕРДОЙ ДИСПЕРСИИ N-[2,4-БИС(1,1-ДИМЕТИЛЭТИЛ)-5-ГИДРОКСИФЕНИЛ]-1,4-ДИГИДРО-4-ОКСОХИНОЛИН-3-КАРБОКСАМИДА (PHARMACEUTICAL COMPOSITIONS COMPRISING A SOLID DISPERSION OF N-[2,4-BIS(1,1-DIMETHYLETHYL)-5-HYDROXYPHENYL]-1,4-DIHYDRO-4-OXOQUINOLINE-3-CARBOXAMIDE) | ⤷ Try a Trial |
South Korea | 20220057663 | 제약 조성물 및 그의 투여 (PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for elexacaftor, ivacaftor, tezacaftor; ivacaftor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2826776 | CR 2021 00013 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EN KOMBINATION AF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
2826776 | C02826776/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019 |
1773816 | 35/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725 |
1773816 | 92761 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
1773816 | C01773816/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014 |
2826776 | PA2021508 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |