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Last Updated: December 4, 2020

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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 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 twenty-two patent family members in forty-five countries.

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

Recent Clinical Trials for ruxolitinib phosphate

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

SponsorPhase
Philipps University Marburg Medical CenterPhase 2
Memorial Sloan Kettering Cancer CenterPhase 2
Hackensack Meridian HealthPhase 2

See all ruxolitinib phosphate clinical trials

Pharmacology for ruxolitinib phosphate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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 202192-004 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 202192-001 Nov 16, 2011 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 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
1966202 145 1-2013 Slovakia   Start Trial FORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
2455382 LUC00016 Luxembourg   Start Trial PRODUCT NAME: RUXOLITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001-016 20150313
1966202 CR 2013 00005 Denmark   Start Trial PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823
1966202 92137 Luxembourg   Start Trial PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Harvard Business School
Moodys
Baxter
Mallinckrodt

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