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Last Updated: December 7, 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 patent protection?

Ruxolitinib phosphate is the generic ingredient in two branded drugs marketed by Incyte Corp and is included in two NDAs. There are thirteen 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 eighty-six patent family members in forty-seven 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
Zhengzhou UniversityPhase 4
Philipps University Marburg Medical 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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-005 Nov 16, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 CR 2017 00018 Denmark ⤷  Try it Free PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: EU/1/12/773/001-016/C(2015)1740 20150313
1966202 8/2013 Austria ⤷  Try it Free PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202 13C0007 France ⤷  Try it Free PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120828
>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
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Express Scripts
McKinsey

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