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Last Updated: December 7, 2022

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 three 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:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 128
Clinical Trials: 90
Patent Applications: 7,097
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in vandetanib?vandetanib excipients list
DailyMed Link:vandetanib at DailyMed
Recent Clinical Trials for vandetanib

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

SponsorPhase
Hoffmann-La RochePhase 3
Eli Lilly and CompanyPhase 3
Loxo Oncology, Inc.Phase 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 022405-001 Apr 6, 2011 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 022405-002 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
>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
Genzyme Europe BV 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
South Korea 20080023270 See Plans and Pricing
Hong Kong 1049664 See Plans and Pricing
Hungary 228176 Kinazolin-származékok, eljárás elõállításukra és az azokat tartalmazó gyógyászati készítmények (QUINAZOLINE DERIVATIVES, PROCESS FOR PRODUCING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for vandetanib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 SPC/GB12/036 United Kingdom See Plans and Pricing PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/749/001 20120217; UK EU/1/11/749/002 20120217
1244647 PA2012015,C1244647 Lithuania See Plans and Pricing PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
1244647 C01244647/01 Switzerland See Plans and Pricing FORMER OWNER: ASTRAZENECA AB, SE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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