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Last Updated: October 25, 2021

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Fedratinib hydrochloride - Generic Drug Details

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What are the generic drug sources for fedratinib hydrochloride and what is the scope of freedom to operate?

Fedratinib hydrochloride is the generic ingredient in one branded drug marketed by Impact and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fedratinib hydrochloride has eighty-two patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for fedratinib hydrochloride
International Patents:82
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 14
What excipients (inactive ingredients) are in fedratinib hydrochloride?fedratinib hydrochloride excipients list
DailyMed Link:fedratinib hydrochloride at DailyMed
Recent Clinical Trials for fedratinib hydrochloride

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

SponsorPhase
University of ChicagoPhase 1
Bristol-Myers SquibbPhase 1
Incyte CorporationPhase 2

See all fedratinib hydrochloride clinical trials

US Patents and Regulatory Information for fedratinib hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 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 fedratinib hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1951684 PA2021509 Lithuania ⤷  Try it Free PRODUCT NAME: FEDRATINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA FARMACINIU POZIURIU PRIIMTINAS JO HIDRATAS, YPAC FEDRATINIBO DIHIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/20/1514 20210208
1951684 LUC00204 Luxembourg ⤷  Try it Free PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
1951684 2021C/513 Belgium ⤷  Try it Free PRODUCT NAME: FEDRATINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Mallinckrodt
McKesson
Medtronic
Boehringer Ingelheim

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