CAPRELSA Drug Patent Profile
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When do Caprelsa patents expire, and what generic alternatives are available?
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
Summary for CAPRELSA
| International Patents: | 40 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 17 |
| Patent Applications: | 5,319 |
| 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 Loss of Exclusivity (LOE) Date for CAPRELSA
*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 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 | 022405-002 | 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 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 |
|---|---|---|---|
| European Patent Office | 1753431 | COMPOSITIONS PHARMACEUTIQUES COMPORTANT ZD6474 (PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474) | ⤷ Sign Up |
| Austria | 330954 | ⤷ Sign Up | |
| Israel | 178928 | PHARMACEUTICAL COMPOSITIONS COMPRISING ZD6474 OR A PHARMACEUTICALLY-ACCEPTABLE SALT THEREOF | ⤷ 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 | 1290028-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217 |
| 1244647 | 2012/029 | Ireland | ⤷ Sign Up | PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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