DrugPatentWatch Database Preview
CAPRELSA Drug Profile
» See Plans and Pricing
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 four 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.
US ANDA Litigation and 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: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 15 |
| Patent Applications: | 1,362 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CAPRELSA |
| DailyMed Link: | CAPRELSA at DailyMed |
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 |
|---|---|
| University College, London | Phase 1 |
| AstraZeneca | Phase 1 |
| Cancer Research UK | Phase 1 |
Pharmacology for CAPRELSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors P-Glycoprotein Inhibitors Organic Cation Transporter 2 Inhibitors |
US Patents and Regulatory Information for CAPRELSA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 | Start Trial | Start Trial |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CAPRELSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Uruguay | 28901 | Start Trial |
| Slovenia | 1244647 | Start Trial |
| Ukraine | 72946 | Start Trial |
| Poland | 1753431 | Start Trial |
| Iceland | 2284 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CAPRELSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1244647 | CA 2012 00032 | Denmark | Start Trial | |
| 1244647 | C01244647/01 | Switzerland | Start Trial | FORMER OWNER: ASTRAZENECA AB, SE |
| 1244647 | SPC/GB12/036 | United Kingdom | Start Trial | 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 | C 2012 023 | Romania | Start Trial | 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 | 2012C/036 | Belgium | Start Trial | 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 |
