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Last Updated: August 3, 2020

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Crizotinib - Generic Drug Details

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What are the generic sources for crizotinib and what is the scope of patent protection?

Crizotinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crizotinib has one hundred and forty-eight patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for crizotinib
International Patents:148
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 78
Clinical Trials: 127
Patent Applications: 286
Formulation / Manufacturing:see details
DailyMed Link:crizotinib at DailyMed
Recent Clinical Trials for crizotinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
AnHeart Therapeutics Inc.Phase 2
TakedaPhase 2

See all crizotinib clinical trials

US Patents and Regulatory Information for crizotinib

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 202570-002 Aug 26, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   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 202570-001 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 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

Supplementary Protection Certificates for crizotinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1786785 12/2013 Austria   Start Trial PRODUCT NAME: CRIZOTINIB, BEVORZUGT IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785 PA2013005,C1786785 Lithuania   Start Trial PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 0121023
1786785 167 5008-2013 Slovakia   Start Trial PRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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