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Last Updated: February 4, 2023

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: 132
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
Loxo Oncology, Inc.Phase 3
Loxo Oncology, Inc. a wholly owned subsidiary of 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 See Plans and Pricing See Plans and Pricing 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 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
>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

Supplementary Protection Certificates for vandetanib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 419 Finland See Plans and Pricing
1244647 1290028-8 Sweden See Plans and Pricing PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647 2012C/036 Belgium See Plans and Pricing PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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