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Last Updated: January 27, 2023

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 fourteen 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 patent family members in forty-eight 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
Memorial Sloan Kettering Cancer CenterPhase 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
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 202192-001 Nov 16, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-005 Nov 16, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
South Korea 102402137 See Plans and Pricing
Slovenia 2426129 See Plans and Pricing
Eurasian Patent Organization 201070013 СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА See Plans and Pricing
Hungary E029035 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ruxolitinib phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1966202 8/2013 Austria See Plans and Pricing PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2455382 17C1013 France See Plans and Pricing PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
1966202 92137 Luxembourg See Plans and Pricing PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1966202 PA2013002 Lithuania See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.