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Last Updated: March 1, 2021

DrugPatentWatch Database Preview

Ivacaftor - Generic Drug Details

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What are the generic sources for ivacaftor and what is the scope of patent protection?

Ivacaftor is the generic ingredient in three branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in five NDAs. There are thirty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has two hundred and forty-one patent family members in thirty-two countries.

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

Summary for ivacaftor
Drug Prices for ivacaftor

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Recent Clinical Trials for ivacaftor

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

SponsorPhase
Children's Hospital of Fudan UniversityPhase 2/Phase 3
Istituto Auxologico ItalianoPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2

See all ivacaftor clinical trials

US Patents and Regulatory Information for 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 SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET, TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-003 Apr 29, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No   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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3170818 2020C/005 Belgium   Start Trial PRODUCT NAME: ORKAMBI (LUMACAFTOR + IVACAFTOR); AUTHORISATION NUMBER AND DATE: EU/1/15/1059 20151124
1773816 132016000022519 Italy   Start Trial PRODUCT NAME: IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(KALYDECO); AUTHORISATION NUMBER(S) AND DATE(S): EU/12/782/001-002, 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 CR 2015 00038 Denmark   Start Trial 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
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 15C0045 France   Start Trial PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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:

Medtronic
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Harvard Business School
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