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

Anatomical Therapeutic Chemical (ATC) Classes for FEDRATINIB HYDROCHLORIDE

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
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	Y

International Patents for FEDRATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2021509
South Africa	200804083	Bi-aryl meta-pyrimidine inhibitors of kinases
European Patent Office	4159216	COMPOSITIONS DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS FOR TREATING MYELOFIBROSIS)
Brazil	PI0618179	inibidores de biaril meta pirimidina de cinases
Israel	226101	פורמולציות קפסולה של n-טרט-בוטיל-3-[(5 -מתיל-2-{[4-(2 -פירולידין-1-אילאתוקסי(פניל[אמינו{פירימידין-4-איל)אמינו]בנזינסולפונאמיד ושימוש בהן להכנת תרופות לטיפול במיאלופיברוזיס (Capsule formulations of n-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide and use thereof in the preparation of medicaments for treating myelofibrosis)
Russian Federation	2012103851	БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ

Supplementary Protection Certificates for FEDRATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	SPC/GB21/026	United Kingdom		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		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	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	LUC00204	Luxembourg		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	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	CR 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