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US Army
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Generated: February 21, 2019

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RUXOLITINIB PHOSPHATE - Generic Drug Details

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

Ruxolitinib phosphate is the generic ingredient in one branded drug marketed by Incyte Corp and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ruxolitinib phosphate has one hundred and eighty patent family members in forty-one countries.

There are two drug master file entries for ruxolitinib phosphate. One supplier is listed for this compound.

Pharmacology for RUXOLITINIB PHOSPHATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for RUXOLITINIB PHOSPHATE
(3R)-3-Cyclopentyl-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)propanenitrile phosphate (1:1)
(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphate
(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphoric acid
(betaR)-beta-Cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazole-1-propanenitrile phosphate
(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate
(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate;Beta-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-(Betar)-1H-pyrazole-1-propanenitrile, phosphate
1092939-17-7
1H-Pyrazole-1-propanenitrile, beta-cyclopentyl-4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betaR)-, phosphate (1:1)
436LRU32H5
AK161128
AKOS024464417
AX8243856
BCP9000783
BIFK0028
CHEBI:66917
CHEMBL1795071
CS-0326
D09960
FT-0674486
HY-50858
INC-424
INCB 018424
INCB-018424 Salt
INCB-18424
INCB-424
INCB018424 SALT
J-501793
Jakafi
Jakafi (TN)
Jakavi
Jakavi (TN)
JFMWPOCYMYGEDM-XFULWGLBSA-N
KS-000006SN
MFCD18452860
MolPort-028-912-691
RL00400
Ruxolitinib (phosphate)
Ruxolitinib phosphate (JAN/USAN)
Ruxolitinib phosphate [USAN]
Ruxolitinib phosphate salt
Ruxolitinib phosphate(INCB018424)
Ruxolitinib, Phosphate Salt
SC-73865
SCHEMBL1369365
UNII-436LRU32H5
W-5760

US Patents and Regulatory Information for RUXOLITINIB PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No ➤ 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 RUXOLITINIB PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017000020 Germany ➤ Sign Up PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
0130003 00072 Estonia ➤ Sign Up PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
0870 Netherlands ➤ Sign Up PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
2013 00005 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Harvard Business School
Accenture
McKinsey
US Department of Justice
Dow
UBS
Mallinckrodt

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