FEDRATINIB HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for fedratinib hydrochloride and what is the scope of patent protection?

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 ten patent family members in forty countries.

One supplier is listed for this compound.

Summary for FEDRATINIB HYDROCHLORIDE

International Patents:	110
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	23
Patent Applications:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FEDRATINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in FEDRATINIB HYDROCHLORIDE?	FEDRATINIB HYDROCHLORIDE excipients list
DailyMed Link:	FEDRATINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FEDRATINIB HYDROCHLORIDE

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

Sponsor	Phase
Joseph Jurcic	Phase 1
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	Phase 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
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes			Y	Y
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes				Y
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes			Y

International Patents for FEDRATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Slovenia	2635282
China	108125923	用于治疗骨髓纤维化的组合物和方法 (Compositions and methods for treating myelofibrosis)
South Korea	20210102192	골수증식성 장애를 치료하는 방법
Russian Federation	2013126121	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА
Ukraine	109412	5-МЕТИЛ-N2-[4-(4-МЕТИЛПІПЕРАЗИН-1-ІЛ)ФЕНІЛ]-ПІРИМІДИН-2,4-ДІАМІН ТА ЙОГО ЗАСТОСУВАННЯ В СПОСОБІ ОДЕРЖАННЯ СПОЛУКИ
Canada	2816957	COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
New Zealand	567851	Bi-aryl meta-pyrimidine inhibitors of kinases

Supplementary Protection Certificates for FEDRATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	C202130029	Spain		PRODUCT NAME: FEDRATINIB, O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, O UN HIDRATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR MONOHIDRATO DE DIHIDROCLORURO DE FEDRATINIB; NATIONAL AUTHORISATION NUMBER: EU/1/20/1514; DATE OF AUTHORISATION: 20210208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1514; DATE OF FIRST AUTHORISATION IN EEA: 20210208
1951684	14/2021	Austria		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	132021000000053	Italy		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	C 2021 012	Romania		PRODUCT NAME: FEDRATINIB, SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, SAU UN HIDRAT ACCEPTABIL FARMACEUTIC AL ACESTUIA, IN PARTICULAR DICLORHIDRAT DE FEDRATINIB MONOHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1514; DATE OF NATIONAL AUTHORISATION: 20210208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1514; DATE OF FIRST AUTHORISATION IN EEA: 20210208
1951684	CA 2021 00011	Denmark		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	C01951684/01	Switzerland		PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
1951684	122021000023	Germany		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