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Last Updated: April 12, 2021

DrugPatentWatch Database Preview

IVACAFTOR; IVACAFTOR, TEZACAFTOR - Generic Drug Details

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What are the generic sources for ivacaftor; ivacaftor, tezacaftor and what is the scope of freedom to operate?

Ivacaftor; ivacaftor, tezacaftor is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has three hundred and forty-three patent family members in thirty-seven countries.

There are three drug master file entries for ivacaftor; ivacaftor, tezacaftor. One supplier is listed for this compound.

Summary for IVACAFTOR; IVACAFTOR, TEZACAFTOR
International Patents:343
US Patents:20
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Suppliers / Packagers: 1
Clinical Trials: 29
DailyMed Link:IVACAFTOR; IVACAFTOR, TEZACAFTOR at DailyMed
Recent Clinical Trials for IVACAFTOR; IVACAFTOR, TEZACAFTOR

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiN/A
University of NottinghamPhase 2
Cystic Fibrosis TrustPhase 2

See all IVACAFTOR; IVACAFTOR, TEZACAFTOR clinical trials

US Patents and Regulatory Information for IVACAFTOR; IVACAFTOR, TEZACAFTOR

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 SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for IVACAFTOR; IVACAFTOR, TEZACAFTOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 92761 Luxembourg   Start 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
1773816 C 2015 027 Romania   Start Trial PRODUCT NAME: IVACAFTOR SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIAN-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1H-CHINOLIN-3-CARBOXAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/12/782/001, EU/1/12/782/002; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/782/001, EU/1/12/782/002; DATE OF FIRST AUTHORISATION IN EEA: 20120723
1773816 237 5014-2015 Slovakia   Start 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
1773816 122015000050 Germany   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Merck

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