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Last Updated: January 27, 2023

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 one NDA. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elexacaftor, ivacaftor, tezacaftor; ivacaftor has four hundred and forty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for elexacaftor, ivacaftor, tezacaftor; ivacaftor
International Patents:442
US Patents:24
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 18
DailyMed Link:elexacaftor, ivacaftor, tezacaftor; ivacaftor at DailyMed
Recent Clinical Trials for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital Medical Center, CincinnatiN/A
University of Southern CaliforniaPhase 4
Imperial College LondonPhase 4

See all elexacaftor, ivacaftor, tezacaftor; ivacaftor clinical trials

US Patents and Regulatory Information for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-002 Jun 8, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-002 Jun 8, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-002 Jun 8, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for elexacaftor, ivacaftor, tezacaftor; ivacaftor

Country Patent Number Title Estimated Expiration
Montenegro 02799 Modulatori ATP-vezujućih kasetnih transportera (Modulators of ATP-binding cassette transporters) See Plans and Pricing
Russian Federation 2007102578 МОДУЛЯТОРЫ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ See Plans and Pricing
Japan 5654979 See Plans and Pricing
Lithuania 1993360 See Plans and Pricing
Lithuania C1773816 See Plans and Pricing
Spain 2554353 See Plans and Pricing
>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 C202130026 Spain See Plans and Pricing PRODUCT NAME: UNA COMBINACION DE (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-IL)-N-(1-(2,3-DIHIDROXIPROPIL)-6-FLUORO-2-(1-HIDROXI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)CICLOPROPANOCARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y(B) N-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1HQUINOLIN-3-CARBOXAMIDA O UNA SALFARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1306; DATE OF AUTHORISATION: 20181031; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1306; DATE OF FIRST AUTHORISATION IN EEA: 20181031
1773816 PA2015028,C1773816 Lithuania See Plans and Pricing PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
2826776 CA 2021 00013 Denmark See Plans and Pricing PRODUCT NAME: A COMBINATION OF (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)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
1773816 15C0045 France See Plans and Pricing 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 See Plans and Pricing 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 CR 2015 00038 Denmark See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Medtronic
Moodys
McKesson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.