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Last Updated: September 20, 2020

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Vandetanib - Generic Drug Details

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What are the generic sources for vandetanib and what is the scope of freedom to operate?

Vandetanib is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vandetanib has one hundred and forty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for vandetanib
International Patents:142
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 111
Clinical Trials: 88
Patent Applications: 666
Formulation / Manufacturing:see details
DailyMed Link:vandetanib at DailyMed
Recent Clinical Trials for vandetanib

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

SponsorPhase
Eli Lilly and CompanyPhase 3
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and CompanyPhase 3
Millennium Pharmaceuticals, Inc.Phase 2

See all vandetanib clinical trials

US Patents and Regulatory Information for vandetanib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial Y 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 vandetanib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 C 2012 023 Romania   Start Trial PRODUCT NAME: VANDETANIB SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/749/001, RO EU/1/11/749/002; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/749/001, EMEA EU/1/11/749/002; DATE OF FIRST AUTHORISATION IN EEA: 20120217
1244647 92057 Luxembourg   Start Trial 92057, EXPIRES: 20251101
1244647 122012000001 Germany   Start Trial PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
1244647 419 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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McKinsey

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