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Last Updated: August 17, 2022

Fedratinib hydrochloride - Generic Drug Details


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What are the generic 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-four patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for fedratinib hydrochloride
International Patents:84
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 20
Clinical Trials: 22
Patent Applications: 18
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
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestPhase 2
Celgene International II S.á.r.l.Phase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impact INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 fedratinib hydrochloride

Country Patent Number Title Estimated Expiration
Ukraine 109411 N-ТРЕТ-БУТИЛ-3-(2-ХЛОР-5-МЕТИЛПІРИМІДИН-4-ІЛАМІНО)БЕНЗОЛСУЛЬФОНАМІД ТА ЙОГО ЗАСТОСУВАННЯ В СПОСОБІ ОДЕРЖАННЯ СПОЛУКИ See Plans and Pricing
Japan 6133211 See Plans and Pricing
Portugal 1951684 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fedratinib hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1951684 CR 2021 00011 Denmark See Plans and Pricing PRODUCT NAME: FEDRATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET FARMACEUTISK ACCEPTABELT HYDRAT DERAF, ISAER FEDRATINIB-DIHYDROCHLORIDMONOHYDRAT; REG. NO/DATE: EU/1/20/1514 20210209
1951684 14/2021 Austria See Plans and Pricing PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN PHARMAZEUTISCH ANNEHMBARES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 (MITTEILUNG) 20210209
1951684 301104 Netherlands See Plans and Pricing PRODUCT NAME: FEDRATINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN FARMACEUTISCH AANVAARDBAAR HYDRAAT DAARVAN, IN HET BIJZONDER FEDRATINIBDIHYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/20/1514 20210209
>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.