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 five hundred and eight patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor
International Patents: | 508 |
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 |
---|---|---|---|
Jordan | P20190125 | ⤷ Free Trial | |
Cyprus | 1122861 | ⤷ Free Trial | |
Brazil | 112020014487 | composições farmacêuticas para tratamento de fi-brose cística | ⤷ Free Trial |
Singapore | 10201913603Q | ⤷ Free Trial | |
Russian Federation | 2692779 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И ЕЕ ВВЕДЕНИЯ (PHARMACEUTICAL COMPOSITION AND INTRODUCTION THEREOF) | ⤷ Free Trial |
Israel | 265430 | תכשירי רוקחות המכילים פיזור מוצק של n-[2,4-ביס(1,1-דימטילאטיל)-5-הידרוקסיפניל]-1,4-דיהידרו-4-אוקסוקוינולין-3-קארבוקסאמיד ושימושים בהם (Pharmaceutical compositions containing a solid dispersion of n-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamode and uses thereof) | ⤷ Free Trial |
China | 112279808 | 囊性纤维化跨膜转导调节因子调节剂 (Modulators of cystic fibrosis transmembrane conductance regulator) | ⤷ Free 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 | 35/2015 | Austria | ⤷ Free 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 |
2826776 | 122021000025 | Germany | ⤷ Free 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 |
1773816 | PA2015028,C1773816 | Lithuania | ⤷ Free Trial | PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723 |
2826776 | 301105 | Netherlands | ⤷ Free 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 | 15C0045 | France | ⤷ Free Trial | PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725 |
1773816 | CA 2015 00038 | Denmark | ⤷ Free Trial | PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723 |
1773816 | 132016000022519 | Italy | ⤷ Free Trial | PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 20120725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Elexacaftor, Tezacaftor, Ivacaftor (ELX-TEZ-IVA)
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