DrugPatentWatch Database Preview
XALKORI Drug Profile
» See Plans and Pricing
When do Xalkori patents expire, and what generic alternatives are available?
Xalkori is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and forty-eight patent family members in forty-seven countries.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
US ANDA Litigation and Generic Entry Outlook for Xalkori
Xalkori was eligible for patent challenges on August 26, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 6, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XALKORI
International Patents: | 148 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 84 |
Clinical Trials: | 40 |
Patent Applications: | 3,159 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XALKORI |
DailyMed Link: | XALKORI at DailyMed |


Generic Entry Opportunity Date for XALKORI
Generic Entry Date for XALKORI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 XALKORI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1 |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
Ulrik Lassen | Phase 2 |
Pharmacology for XALKORI
US Patents and Regulatory Information for XALKORI
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for XALKORI
Country | Patent Number | Estimated Expiration |
---|---|---|
Montenegro | P52808 | Start Trial |
World Intellectual Property Organization (WIPO) | 2007066187 | Start Trial |
South Korea | 101026676 | Start Trial |
Japan | 2008510790 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XALKORI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1786785 | C300587 | Netherlands | Start Trial | PRODUCT NAME: CRIZOTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023 |
1786785 | 449 | Finland | Start Trial | |
1786785 | C01786785/01 | Switzerland | Start Trial | PRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012 |
1786785 | SPC/GB13/018 | United Kingdom | Start Trial | PRODUCT NAME: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/12/793/001 20121026; UK EU/1/12/793/002 20121026; UK EU/1/12/793/003 20121026; UK EU/1/12/793/004 20121026 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |