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Last Updated: May 29, 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
AstraZenecaPhase 2
Samsung Medical CenterPhase 2
Cancer Research UKPhase 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Sign Up ⤷  Sign Up
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ⤷  Sign Up ⤷  Sign Up
>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

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

Country Patent Number Title Estimated Expiration
Montenegro 01505 FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474) ⤷  Sign Up
Denmark 0929530 ⤷  Sign Up
South Korea 20070034499 ⤷  Sign Up
Taiwan I287540 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2005112934 ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
1244647 92057 Luxembourg ⤷  Sign Up 92057, EXPIRES: 20251101
1244647 2012C/036 Belgium ⤷  Sign Up PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221
1244647 122012000057 Germany ⤷  Sign Up PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647 C300543 Netherlands ⤷  Sign Up PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; 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.