Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Moodys
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Harvard Business School
AstraZeneca
McKinsey

Last Updated: November 18, 2019

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Ruxolitinib phosphate - Generic Drug Details

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What are the generic drug sources for ruxolitinib phosphate and what is the scope of freedom to operate?

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

Ruxolitinib phosphate has two hundred and six patent family members in forty-two countries.

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

Recent Clinical Trials for ruxolitinib phosphate

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SponsorPhase
Hackensack Meridian HealthPhase 2
Memorial Sloan Kettering Cancer CenterPhase 2
Southwest Oncology GroupPhase 2

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Recent Litigation for ruxolitinib phosphate

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PTAB Litigation
PetitionerDate
Concert Pharmaceuticals, Inc.2017-06-27

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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
(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
(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate
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
EX-A2660
FT-0674486
HY-50858
INC-424
INCB 018424
INCB 018424 phosphate
INCB-018424 Salt
INCB-18424
INCB-424
INCB018424 SALT
J-501793
Jakafi
Jakafi (TN)
Jakavi
Jakavi (TN)
JFMWPOCYMYGEDM-XFULWGLBSA-N
KS-000006SN
MolPort-028-912-691
OR302722
RL00400
Ruxolitinib (phosphate)
Ruxolitinib phosphate (JAN/USAN)
Ruxolitinib phosphate [USAN]
Ruxolitinib phosphate salt
Ruxolitinib phosphate(INCB018424)
Ruxolitinib, Phosphate Salt
SB20028
SC-73865
SCHEMBL1369365
UNII-436LRU32H5
W-5760
Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
JAKAFI TABLET;ORAL ruxolitinib phosphate 202192 2015-12-17

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 202192-002 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-001 Nov 16, 2011 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-001 Nov 16, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-001 Nov 16, 2011 RX Yes No   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

Supplementary Protection Certificates for ruxolitinib phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2455382 122017000020 Germany   Start Trial PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
1966202 SPC/GB13/005 United Kingdom   Start Trial PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/12/773/001 20120828; UK EU/1/12/773/002 20120828; UK EU/1/12/773/003 20120828
1966202 122013000015 Germany   Start Trial PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202 C 2013 005 Romania   Start Trial PRODUCT NAME: RUXOLITINIB SAU O SARE FARMACEUTIC ACCEPTABILA AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/773/001, RO EU/1/12/773/002, RO EU/1/12/773/003; DATE OF NATIONAL AUTHORISATION: 20120823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/773/001, EMEA EU/1/12/773/002, EMEA EU/1/12/773/003; DATE OF FIRST AUTHORISATION IN EEA: 20120823
1966202 PA2013002 Lithuania   Start Trial
1966202 92137 Luxembourg   Start Trial PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1966202 CA 2013 00005 Denmark   Start Trial
>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
Medtronic
AstraZeneca
Boehringer Ingelheim

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