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Last Updated: March 28, 2024

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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 is one patent protecting this drug.

This drug has forty patent family members in thirty-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 Loss of Exclusivity (LOE) 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 one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CAPRELSA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  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
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes ⤷  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 CAPRELSA

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 022405-002 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
>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
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 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: ⤷  Try a Trial

Patent: 0045
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05244650
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 39841
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0511253
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 65513
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1031303
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0090547
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 09500
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 53431
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 53431
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005016105
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 99220
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8928
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 40947
Estimated Expiration: ⤷  Try a Trial

Patent: 07538060
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8868
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013501
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 505
Estimated Expiration: ⤷  Try a Trial

Patent: 778
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0931
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8324
Estimated Expiration: ⤷  Try a Trial

Patent: 065735
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 53431
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 53431
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 83343
Estimated Expiration: ⤷  Try a Trial

Patent: 06145357
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 260133
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 112
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 53431
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609110
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1192935
Estimated Expiration: ⤷  Try a Trial

Patent: 070034499
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 30025
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 55269
Estimated Expiration: ⤷  Try a Trial

Patent: 0612953
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 732
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 11378
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 901
Estimated Expiration: ⤷  Try a Trial

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
South Korea 100881104 ⤷  Try a Trial
Japan 2001500891 ⤷  Try a Trial
Hong Kong 1049664 ⤷  Try a Trial
Hungary 9902850 ⤷  Try a Trial
Japan 3522727 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CAPRELSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1244647 1290028-8 Sweden ⤷  Try a Trial PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647 CA 2012 00032 Denmark ⤷  Try a Trial
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 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
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
>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.