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Last Updated: March 28, 2024

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 two branded drugs marketed by Incyte Corp and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ruxolitinib phosphate has three hundred and twenty-two patent family members in forty-eight countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ruxolitinib phosphate
Generic Entry Dates for ruxolitinib phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for ruxolitinib phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OPZELURA Cream ruxolitinib phosphate 1.5% 215309 1 2023-07-31
JAKAFI Tablets ruxolitinib phosphate 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg 202192 1 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 202192-005 Nov 16, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-001 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ruxolitinib phosphate

Country Patent Number Title Estimated Expiration
Singapore 10202003901U HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3-B]PYRIMIDINES AS JANUS KINASE INHIBITORS ⤷  Try a Trial
Tunisia 2009000514 SALTS OF THE JANUS KINASE INHIBITOR (R) -3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE ⤷  Try a Trial
Taiwan 202112377 Topical treatment of vitiligo by a JAK inhibitor ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ruxolitinib phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2455382 132017000044713 Italy ⤷  Try a Trial PRODUCT NAME: RUXOLITINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(JAKAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/773/001-016, 20150313
2455382 CR 2017 00018 Denmark ⤷  Try a Trial 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
2455382 LUC00016 Luxembourg ⤷  Try a Trial PRODUCT NAME: RUXOLITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001-016 20150313
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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