You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 17, 2024

Fedratinib hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 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 ⤷  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 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 ⤷  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
South Korea 20180122029 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS) ⤷  Try a Trial
Lithuania 2635282 ⤷  Try a Trial
South Korea 20080066066 BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES ⤷  Try a Trial
Brazil 112013011184 composições e métodos para tratamento de mielofibrose ⤷  Try a Trial
Japan 5814903 ⤷  Try a Trial
European Patent Office 3856169 PROCÉDÉS DE TRAITEMENT DE TROUBLES MYÉLOPROLIFÉRATIFS (METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS) ⤷  Try a Trial
South Korea 101494468 ⤷  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 PA2021509 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 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 14/2021 Austria ⤷  Try a Trial 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 C01951684/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
1951684 SPC/GB21/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/20/1514(FOR NI) 20210209; UK FURTHER MA ON IPSUM 20210209
1951684 122021000023 Germany ⤷  Try a Trial PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER EIN PHARMAZEUTISCH UNBEDENKLICHES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 20210208
1951684 LUC00204 Luxembourg ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.