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Last Updated: February 7, 2023

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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fedratinib hydrochloride has ninety-nine patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for fedratinib hydrochloride
International Patents:99
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 23
Patent Applications: 24
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
Joseph JurcicPhase 1
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestPhase 2
Celgene International II S.á.r.l.Phase 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 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
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 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
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
Peru 20140389 COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS See Plans and Pricing
New Zealand 611363 Compositions and methods for treating myelofibrosis See Plans and Pricing
Brazil 122021011788 Inibidores de biaril meta pirimidina de cinases, composição farmacêutica e processo para preparar uma composição farmacêutica See Plans and Pricing
Taiwan 201306882 Compositions and methods for treating myelofibrosis See Plans and Pricing
Nicaragua 201300038 COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS See Plans and Pricing
Lithuania 2635282 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 C01951684/01 Switzerland See Plans and Pricing PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
1951684 2021C/513 Belgium See Plans and Pricing 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
1951684 2190016-2 Sweden See Plans and Pricing PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/20/1514 20210209
1951684 132021000000053 Italy See Plans and Pricing PRODUCT NAME: FEDRATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO IDRATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE FEDRATINIB DICLORIDRATO MONOIDRATO(INREBIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1514, 20210209
1951684 LUC00204 Luxembourg See Plans and Pricing 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 21C1019 France See Plans and Pricing 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; REGISTRATION NO/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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