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Generated: May 24, 2019

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XALKORI Drug Profile

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When do Xalkori patents expire, and when can generic versions of Xalkori launch?

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-five 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.

Drug patent expirations by year for XALKORI
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.

Synonyms for XALKORI
(R)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1H-pyrazol-4-yl)pyridin-2-am ine
(R)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1H-pyrazol-4-yl)pyridin-2-amine
(R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine
(R)-crizotinib
2-Pyridinamine, 3-((1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(4-piperidinyl)-1H-pyrazol-4-yl)-
3-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(4-piperidinyl)-1h-pyrazol-4-yl)pyridin-2-amine
3-(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy-5-1-(4-piperidinyl)-1H-pyrazol-4-yl-2-Pyridinamine
3-[(1r)-1-(2,6-Dichloro-3-Fluorophenyl)ethoxy]-5-(1-Piperidin-4-Yl-1h-Pyrazol-4-Yl)pyridin-2-Amine
3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[
3-[(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(4-piperidinyl)-1H-pyrazol-4-yl]-2-pyridinamine
3-[(1R)-1-(2,6-DICHLORO-3-FLUOROPHENYL)ETHOXY]-5-[1-(4-PIPERIDINYL)-1H-PYRAZOL-4-YL]PYRIDIN-2-AMINE
3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine
3-[(R)-1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine
399P525
53AH36668S
877399-52-5
877399-52-5, 877399-53-6 (acetate)
912279-98-2
AB0027203
ABP000131
AK172044
AKOS015901233
AKOS015995207
AMX10152
ANW-47749
AOB2688
BB 0261738
BC622990
BCPP000116
BDBM50306682
BRD-K78431006-001-01-1
BRD-K78431006-001-03-7
C21H22Cl2FN5O
CHEBI:64310
CHEMBL601719
Crizotinib
Crizotinib (JAN/USAN/INN)
Crizotinib (PF-02341066)
Crizotinib (PF-2341066)
Crizotinib [USAN:INN]
Crizotinib, >=98% (HPLC)
Crizotinib; PF 2341066
crizotinibum
CTK5F8952
D09731
DB08865
EN002685
EX-A096
FT-0665224
GS-6178
GTPL4903
HY-50878
I14-14837
J-510370
KB-26391
KIN0000318
KS-0000075X
KTEIFNKAUNYNJU-GFCCVEGCSA-N
MolPort-009-679-404
NCGC00250400-01
NCGC00250400-09
NCGC00250400-12
NSC-749005
NSC749005
PB11015
PF 02341066
PF 2341066
PF 2341066;(R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine
PF-02341066
PF-02341066 (Crizotinib)
PF-2341066
PF-2341066 - Crizotinib
PF-2341066 (Crizotinib)
PF-2341066,Crizotinib
PF-2341066(Crizotinib)
PF2341066
PubChem19322
Q-3209
QCR-32
RL05464
SC-48062
SCHEMBL93829
SW202555-3
SYN1139
TX-017903
UNII-53AH36668S
VGH
W9013
Xalkori (TN)
ZINC35902489

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-001 Aug 26, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv XALKORI crizotinib CAPSULE;ORAL 202570-002 Aug 26, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for XALKORI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1786785 1390008-9 Sweden ➤ Sign Up PRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023; PERIOD OF VALIDITY (FROM - UNTIL): 2025-08-16 - 2027-10-25
1786785 2013/009 Ireland ➤ Sign Up PRODUCT NAME: PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/12/793/001 EU/1/12/793/004 20121023
1786785 C01786785/01 Switzerland ➤ Sign Up PRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
1786785 12/2013 Austria ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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