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Last Updated: March 1, 2021

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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-four 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
Hackensack Meridian HealthPhase 2
Memorial Sloan Kettering Cancer CenterPhase 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 202192-002 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
>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 122013000015 Germany   Start Trial PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2455382 300870 Netherlands   Start Trial PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Harvard Business School
Mallinckrodt
Baxter
Boehringer Ingelheim

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