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Last Updated: April 13, 2024

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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vandetanib has forty patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for vandetanib
International Patents:40
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 138
Clinical Trials: 90
Patent Applications: 7,474
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in vandetanib?vandetanib excipients list
DailyMed Link:vandetanib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vandetanib
Generic Entry Date for vandetanib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for vandetanib

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

SponsorPhase
Hoffmann-La RochePhase 3
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and CompanyPhase 3
Eli Lilly and CompanyPhase 3

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

Expired US Patents for vandetanib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for vandetanib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi B.V. Caprelsa vandetanib EMEA/H/C/002315
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.Caprelsa is indicated in adults, children and adolescents aged 5 years and older.For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
Authorised no no no 2012-02-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for vandetanib

Country Patent Number Title Estimated Expiration
Israel 178928 PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474 OR A PHARMACEUTICALLY-ACCEPTABLE SALT THEREOF ⤷  Try a Trial
European Patent Office 1753431 COMPOSITIONS PHARMACEUTIQUES COMPORTANT ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474) ⤷  Try a Trial
Brazil PI0511253 composição farmacêutica ⤷  Try a Trial
Denmark 1753431 ⤷  Try a Trial
United Kingdom 0411378 ⤷  Try a Trial
Montenegro 01505 FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for vandetanib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 12C0048 France ⤷  Try a Trial PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
1244647 300543 Netherlands ⤷  Try a Trial PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647 122012000057 Germany ⤷  Try a Trial PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647 PA2012015 Lithuania ⤷  Try a Trial PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1244647 C 2012 023 Romania ⤷  Try a 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 2012/029 Ireland ⤷  Try a Trial PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.