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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 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.
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: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 15 |
| Patent Applications: | 5,313 |
| 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 |
|---|---|
| AstraZeneca | Phase 1 |
| Cancer Research UK | Phase 1 |
| University College, London | Phase 1 |
Pharmacology for CAPRELSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors P-Glycoprotein Inhibitors Organic Cation Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CAPRELSA
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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| >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 | ⤷ Try it Free | ⤷ Try it Free |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | ⤷ Try it Free | ⤷ Try it Free |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-001 | Apr 6, 2011 | ⤷ Try it Free | ⤷ Try it Free |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405-002 | Apr 6, 2011 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CAPRELSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Serbia | 51112 | ⤷ Try it Free |
| Malaysia | 129540 | ⤷ Try it Free |
| Spain | 2185999 | ⤷ Try it Free |
| United Kingdom | 0411378 | ⤷ Try it Free |
| Iceland | 2284 | ⤷ Try it Free |
| Hungary | 228176 | ⤷ Try it Free |
| Canada | 2263319 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CAPRELSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1244647 | 122012000057 | Germany | ⤷ Try it Free | PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217 |
| 1244647 | CA 2012 00032 | Denmark | ⤷ Try it Free | |
| 1244647 | 419 | Finland | ⤷ Try it Free | |
| 1244647 | 12C0048 | France | ⤷ Try it Free | PRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217 |
| 1244647 | 2012C/036 | Belgium | ⤷ Try it Free | PRODUCT NAME: VANDETANIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/749/001 20120221 |
| 1244647 | 2012/029 | Ireland | ⤷ Try it Free | PRODUCT NAME: VANDETANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217 |
| 1244647 | 300543 | Netherlands | ⤷ Try it Free | PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
