VANDETANIB - Generic Drug Details

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What are the generic drug 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Vandetanib has forty patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for VANDETANIB

International Patents:	40
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	90
Patent Applications:	7,474
What excipients (inactive ingredients) are in VANDETANIB?	VANDETANIB excipients list
DailyMed Link:	VANDETANIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VANDETANIB

Generic Entry Date for VANDETANIB^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 VANDETANIB

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

Sponsor	Phase
Hoffmann-La Roche	Phase 3
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company	Phase 3
Eli Lilly and Company	Phase 3

See all VANDETANIB clinical trials

Pharmacology for VANDETANIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VANDETANIB

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VANDETANIB

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No	⤷ 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 VANDETANIB

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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
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 VANDETANIB

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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 VANDETANIB

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Country	Patent Number	Title	Estimated Expiration
China	101031303	Pharmaceutical compositions comprising zd6474	⤷ Sign Up
South Africa	200609110	Pharmaceutical compositions comprising ZD6474	⤷ Sign Up
Russian Federation	2383343	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ZD6474 (PHRAMACEUTICAL COMPOSITIONS CONTAINING ZD6474)	⤷ Sign Up
Mexico	PA06013501	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN ED6474. (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474.)	⤷ Sign Up
Montenegro	02778	FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474)	⤷ Sign Up
Montenegro	01505	FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VANDETANIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1244647	C 2012 023	Romania	⤷ Sign Up	PRODUCT NAME: VANDETANIB SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/749/001, RO EU/1/11/749/002; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/749/001, EMEA EU/1/11/749/002; DATE OF FIRST AUTHORISATION IN EEA: 20120217
1244647	1290028-8	Sweden	⤷ Sign Up	PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
1244647	300543	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
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	PA2012015	Lithuania	⤷ Sign Up	PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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