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
Summary for CAPRELSA
International Patents: | 142 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 131 |
Clinical Trials: | 17 |
Patent Applications: | 3,800 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CAPRELSA |
What excipients (inactive ingredients) are in CAPRELSA? | CAPRELSA excipients list |
DailyMed Link: | CAPRELSA at DailyMed |


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
Sponsor | Phase |
---|---|
Samsung Medical Center | Phase 2 |
AstraZeneca | Phase 2 |
AstraZeneca | Phase 1 |
Pharmacology for CAPRELSA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CAPRELSA
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 |