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Last Updated: February 7, 2023

CAPRELSA Drug Patent Profile


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Which patents cover Caprelsa, and when can generic versions of Caprelsa launch?

Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in CAPRELSA is vandetanib. One supplier is listed for this compound. Additional details are available on the vandetanib profile page.

DrugPatentWatch® Generic Entry Outlook for Caprelsa

Caprelsa was eligible for patent challenges on April 6, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CAPRELSA
Drug patent expirations by year for CAPRELSA
Drug Prices for CAPRELSA

See drug prices for CAPRELSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for CAPRELSA
Generic Entry Date for CAPRELSA*:
Constraining patent/regulatory exclusivity:
NDA:
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 CAPRELSA

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

SponsorPhase
Samsung Medical CenterPhase 2
AstraZenecaPhase 2
AstraZenecaPhase 1

See all CAPRELSA clinical trials

US Patents and Regulatory Information for CAPRELSA

CAPRELSA is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAPRELSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CAPRELSA

Pharmaceutical compositions comprising ZD6474
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Quinazoline derivatives as VEGF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN PATIENTS HAVING SYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER, WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE

Quinazoline derivatives and pharmaceutical compositions containing them
Patent Number: See Plans and Pricing
Patent Expiration: 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
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 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 022405-001 Apr 6, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 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 CAPRELSA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 022405-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CAPRELSA

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 CAPRELSA

When does loss-of-exclusivity occur for CAPRELSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9059
Estimated Expiration: See Plans and Pricing

Patent: 0045
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05244650
Estimated Expiration: See Plans and Pricing

Austria

Patent: 9841
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0511253
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65513
Estimated Expiration: See Plans and Pricing

China

Patent: 1031303
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0090547
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 09500
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 53431
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 53431
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005016105
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99220
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8928
Estimated Expiration: See Plans and Pricing

Japan

Patent: 40947
Estimated Expiration: See Plans and Pricing

Patent: 07538060
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8868
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06013501
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 505
Estimated Expiration: See Plans and Pricing

Patent: 778
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0931
Estimated Expiration: See Plans and Pricing

Norway

Patent: 8324
Estimated Expiration: See Plans and Pricing

Patent: 065735
Estimated Expiration: See Plans and Pricing

Poland

Patent: 53431
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 53431
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 83343
Estimated Expiration: See Plans and Pricing

Patent: 06145357
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 39
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 112
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 53431
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0609110
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1192935
Estimated Expiration: See Plans and Pricing

Patent: 070034499
Estimated Expiration: See Plans and Pricing

Spain

Patent: 30025
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 55269
Estimated Expiration: See Plans and Pricing

Patent: 0612953
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 732
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 11378
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 901
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAPRELSA around the world.

Country Patent Number Title Estimated Expiration
Japan 3438818 See Plans and Pricing
Japan 2004002406 QUINAZOLINE DERIVATIVE AND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME See Plans and Pricing
China 100376567 See Plans and Pricing
Brazil PI0015203 derivado de quinazolina, composição farmacêutica, e, uso de um composto See Plans and Pricing
Austria 439841 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CAPRELSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 12C0048 France See Plans and Pricing PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
1244647 2012/029 Ireland See Plans and Pricing PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647 300543 Netherlands See Plans and Pricing PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
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 CA 2012 00032 Denmark See Plans and Pricing
>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.