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Last Updated: November 13, 2019

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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 nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; ivacaftor, tezacaftor has two hundred and forty-eight patent family members in thirty-four 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:248
US Patents:19
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Suppliers / Packagers: 1
Clinical Trials: 22
DailyMed Link:ivacaftor; ivacaftor, tezacaftor at DailyMed
Recent Clinical Trials for ivacaftor; ivacaftor, tezacaftor

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SponsorPhase
Cystic Fibrosis FoundationPhase 2
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 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes   Start Trial   Start Trial Y 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
>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 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
1773816 PA2015028,C1773816 Lithuania   Start Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
1773816 2015/036 Ireland   Start 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 300748 Netherlands   Start Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 C300748 Netherlands   Start Trial 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
AstraZeneca
McKinsey
Moodys
Colorcon

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