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Last Updated: April 22, 2024

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 Bristol-myers 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 one hundred and nine patent family members in forty countries.

One supplier is listed for this compound.

Summary for fedratinib hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fedratinib hydrochloride
Generic Entry Date for fedratinib hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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 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

Paragraph IV (Patent) Challenges for FEDRATINIB HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INREBIC Capsules fedratinib hydrochloride 100 mg 212327 1 2023-08-16

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
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  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 fedratinib hydrochloride

Country Patent Number Title Estimated Expiration
Lithuania PA2021509 ⤷  Try a Trial
Singapore 190134 COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS ⤷  Try a Trial
South Korea 20130137647 COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS ⤷  Try a Trial
Lithuania 1951684 ⤷  Try a Trial
China 101370792 Bi-aryl meta-pyrimidine inhibitors of kinases ⤷  Try a Trial
Taiwan I531389 ⤷  Try a Trial
Hungary E028987 ⤷  Try a Trial
>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 ⤷  Try a Trial 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 PA2021509,C1951684 Lithuania ⤷  Try a Trial 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 301104 Netherlands ⤷  Try a Trial 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
1951684 2021C/513 Belgium ⤷  Try a Trial 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 21C1019 France ⤷  Try a Trial 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
1951684 2190016-2 Sweden ⤷  Try a Trial 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 C01951684/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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