Elexacaftor, ivacaftor, tezacaftor; ivacaftor - Generic Drug Details
✉ Email this page to a colleague
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-nine patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor
International Patents: | 499 |
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 |
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 |
---|---|---|---|
Japan | 2009522278 | ⤷ Sign Up | |
Canada | 2783314 | 4-OXO-1H-QUINOLINE-3-CARBOXAMIDES UTILES COMME MODULATEURS DES TRANSPORTEURS DE CASSETTE SE LIANT A L'ATP (4-OXO-1H-QUINOLINE-3-CARBOXAMIDES AS MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS) | ⤷ Sign Up |
Japan | 2014111656 | PHARMACEUTICAL COMPOSITION AND ADMINISTRATIONS THEREOF | ⤷ Sign Up |
Japan | 2020094068 | (R)−1−(2,2−ジフルオロベンゾ[d][1,3]ジオキソール−5−イル)−N−(1−(2,3−ジヒドロキシプロピル)−6−フルオロ−2−(1−ヒドロキシ−2−メチルプロパン−2−イル)−1H−インドール−5−イル)シクロプロパンカルボキサミドの固体形態 (SOLID FORM 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) | ⤷ Sign Up |
Russian Federation | 2012109390 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБЫ ЕЕ ВВЕДЕНИЯ | ⤷ Sign Up |
Chile | 2017000824 | Moduladores de regulador de conducta de transmembranas de fibrosis cística | ⤷ Sign Up |
Denmark | 2328618 | ⤷ Sign Up | |
>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 | C20210011 00330 | Estonia | ⤷ Sign Up | PRODUCT NAME: TESAKAFTOOR/IVAKAFTOOR;REG NO/DATE: EU/1/18/1306 06.11.2018 |
1773816 | 92761 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725 |
2826776 | PA2021508,C2826776 | Lithuania | ⤷ Sign Up | 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 FARMACISKAI PRIIMTINOS JO DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
1773816 | PA2015028 | Lithuania | ⤷ Sign Up | PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723 |
2826776 | C02826776/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TEZACAFTOR UND IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66742 10.05.2019 |
2826776 | PA2021508 | Lithuania | ⤷ Sign Up | 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 | C300748 | Netherlands | ⤷ Sign Up | PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |