ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - Generic Drug Details
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What are the generic drug 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 |
---|---|
University of North Carolina, Chapel Hill | Phase 4 |
Chiesi USA, Inc. | Phase 4 |
Emory University | Phase 4 |
See all ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR clinical trials
US Patents and Regulatory Information for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
International Patents for ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2012006764 | 4-OXO-1H -QUINOLIN-3- CARBOXAMIDAS COMO MODULADORES DE TRANSPORTADORES DEL CASETE DE UNION CON ATP. (4 -OXO- IH -QUINOLINE- 3 - CARBOXAMIDES AS MODULATORS OF ATP -BINDING CASSETTE TRANSPORTERS.) | ⤷ Try a Trial |
Morocco | 54649 | MODULATEURS DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE LA FIBROSE KYSTIQUE | ⤷ Try a Trial |
Peru | 20191304 | MODULADOR DEL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA, COMPOSICIONES FARMACEUTICAS, METODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR | ⤷ Try a Trial |
Canada | 2869945 | MODULATEURS DES TRANSPORTEURS DE CASSETTES DE LIAISON DE L'ATP (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | ⤷ Try a Trial |
Japan | 2015120762 | ATP結合カセット輸送体の調節剤 (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | ⤷ Try a Trial |
Hungary | E052205 | ⤷ 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 |
---|---|---|---|---|
1773816 | 237 5014-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725 |
2826776 | C20210011 00330 | Estonia | ⤷ Try a Trial | PRODUCT NAME: TESAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/18/1306 06.11.2018 |
1773816 | C300748 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
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 |
1773816 | CR 2015 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |