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 |
| The Marcus Foundation, Inc. | 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 |
|---|---|---|---|
| Chile | 2017000824 | Moduladores de regulador de conducta de transmembranas de fibrosis cística | ⤷ Try a Trial |
| New Zealand | 597823 | Pharmaceutical composition and administrations thereof | ⤷ Try a Trial |
| European Patent Office | 1773816 | Modulateurs de transporteurs de cassette de liaison a l'ATP (Modulators of ATP-binding cassette transporters) | ⤷ Try a Trial |
| New Zealand | 718018 | Solid forms of (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) cyclopropanecarboxamide | ⤷ Try a Trial |
| Mexico | 2021013639 | FORMA CRISTALINA DEL COMPUESTO 1, UN MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, PROCESOS PARA SU PREPARACIÓN, COMPOSICIONES FARMACÉUTICAS DEL COMPUESTO 1, Y SU USO EN EL TRATAMIENTO DE FIBROSIS QUÍSTICA. (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR.) | ⤷ Try a Trial |
| Hungary | E035931 | ⤷ Try a Trial | |
| Japan | 2012056963 | MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER | ⤷ 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 | 2015/036 | Ireland | ⤷ Try a Trial | PRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723 |
| 1773816 | PA2015028 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
| 2826776 | C20210011 00330 | Estonia | ⤷ Try a Trial | PRODUCT NAME: TESAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/18/1306 06.11.2018 |
| 2826776 | 122021000025 | Germany | ⤷ Try a Trial | PRODUCT NAME: EINE KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANCARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
| 2826776 | 301105 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPAANCARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1306 20181106 |
| 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 | 21C1018 | France | ⤷ Try a Trial | PRODUCT NAME: TEZACAFTOR ET IVACAFTOR, SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1306 20181106 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
