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*:
Constraining patent/regulatory exclusivity:
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 |
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
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 | ⤷ 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
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 | 022405-001 | 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 | 022405-001 | 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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 602005016105 | ⤷ Sign Up | |
European Patent Office | 1753431 | COMPOSITIONS PHARMACEUTIQUES COMPORTANT ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474) | ⤷ Sign Up |
New Zealand | 550931 | Pharmaceutical compositions comprising ZD6474 | ⤷ Sign Up |
Russian Federation | 2006145357 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ZD6474 | ⤷ Sign Up |
Japan | 2007538060 | ⤷ Sign Up | |
Slovenia | 1753431 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VANDETANIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 | SPC/GB12/036 | United Kingdom | ⤷ Sign Up | 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 | 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 | 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,C1244647 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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