Fedratinib hydrochloride - Generic Drug Details

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 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

Constraining patent/regulatory exclusivity:

10,391,094

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	11,400,092
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes	7,825,246			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	8,138,199
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes	7,528,143		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	10,391,094		Y

International Patents for fedratinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	103282036	Compositions and methods for treating myelofibrosis
South Korea	20080066066	BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES
Japan	2013541595
Brazil	112021005518	métodos para tratar distúrbios mieloproliferativos
China	113286584	治疗骨髓增生性病症的方法 (METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS)
Peru	20140389	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Morocco	53741	PROCÉDÉS DE TRAITEMENT DE TROUBLES MYÉLOPROLIFÉRATIFS

Supplementary Protection Certificates for fedratinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	C01951684/01	Switzerland		PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
1951684	PA2021509,C1951684	Lithuania		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	2190016-2	Sweden		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	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	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
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	PA2021509	Lithuania		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

Fedratinib hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fedratinib Hydrochloride

Introduction

Fedratinib hydrochloride, marketed under the brand name INREBIC, is a selective Janus kinase 2 (JAK2) inhibitor approved by the U.S. Food and Drug Administration (FDA) in August 2019 for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Projections

The fedratinib market has shown significant growth potential. As of 2023, the market size was valued at USD 230 million and is projected to reach USD 601 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 15% from 2024 to 2031[3].

Revenue Performance

In 2023, INREBIC generated $110 million in revenues. Projected sales are expected to be between $300 million to $500 million by 2028, indicating a robust financial trajectory for the drug[5].

Key Drivers of Market Growth

Several factors are driving the growth of the fedratinib market:

• Increasing Diagnoses: The rising number of myelofibrosis diagnoses is increasing the demand for effective treatments like fedratinib[3].
• Alternative Treatment Option: Fedratinib serves as a viable alternative for patients who cannot tolerate other treatments, expanding its market reach[3].
• Ongoing Clinical Trials: Continued research and clinical trials exploring the use of fedratinib in combination therapies or for additional blood malignancies are expected to enhance its market prospects[3].

Market Segmentation

The fedratinib market is segmented based on type (Janus Kinase Inhibitors, Antineoplastic Agents, Small Molecule Drugs) and application (Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[3].

Safety and Efficacy

Fedratinib has demonstrated significant efficacy in reducing splenomegaly and myelofibrosis symptom burden, as shown in the phase II and III JAKARTA-2 and JAKARTA trials. However, it is associated with common adverse effects such as anemia, gastrointestinal symptoms, and elevation in liver transaminases. Early concerns about Wernicke's encephalopathy were addressed, and the clinical hold was lifted in 2017[1][4].

Competitive Landscape

The market for fedratinib is influenced by several key players, including Celgene Corporation, Impact Biomedicines Inc., Novartis, Incyte Corporation, and others. The acquisition of Impact Biomedicines by Celgene in 2018 and subsequent integration into Bristol Myers Squibb have played significant roles in the drug's development and marketing[3][4].

Regulatory and Patent Landscape

Fedratinib was approved by the FDA in August 2019, and its patent profile indicates that it remains under patent protection. The drug's exclusivity and patent expiration dates are crucial for understanding its long-term market viability[5].

Challenges and Limitations

Despite the positive growth projections, the fedratinib market faces several challenges:

• Safety Concerns: The drug's safety profile, including boxed warnings and potential major adverse effects, may restrict its adoption[3].
• Generic Competition: The possibility of generic competition after patent expiration could impact future market growth[3].

Future Prospects

The future growth of the fedratinib market is contingent on several factors:

• Enhancing Safety Profile: Ongoing research aimed at improving the safety profile of fedratinib could expand its use and acceptance[3].
• Exploring Additional Indications: Clinical trials investigating the use of fedratinib in other blood malignancies or combination therapies could further boost its market potential[3].

Conclusion

Fedratinib hydrochloride, with its approval and growing market presence, is poised to make a significant impact in the treatment of myelofibrosis. The drug's financial trajectory, driven by increasing diagnoses and its role as an alternative treatment, suggests a promising future. However, addressing safety concerns and navigating potential generic competition will be crucial for sustained market growth.

Key Takeaways

• Market Growth: The fedratinib market is expected to grow from USD 230 million in 2023 to USD 601 million by 2031.
• Revenue Projections: INREBIC is projected to generate between $300 million to $500 million by 2028.
• Drivers: Increasing diagnoses, alternative treatment options, and ongoing clinical trials drive market growth.
• Challenges: Safety concerns and potential generic competition are key limitations.
• Future Prospects: Enhancing the safety profile and exploring additional indications are critical for future growth.

FAQs

What is fedratinib hydrochloride used for?

Fedratinib hydrochloride is used for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis.

When was fedratinib approved by the FDA?

Fedratinib was approved by the FDA in August 2019.

What are the common adverse effects associated with fedratinib?

Common adverse effects include anemia, gastrointestinal symptoms, and elevation in liver transaminases.

What is the projected market size of fedratinib by 2031?

The market size is projected to reach USD 601 million by 2031.

Which companies are key players in the fedratinib market?

Key players include Celgene Corporation, Impact Biomedicines Inc., Novartis, Incyte Corporation, and others.

Sources

1. Fedratinib hydrochloride to treat intermediate-2 or high-risk primary or secondary myelofibrosis. PubMed.
2. 2020 Annual Report - Bristol Myers Squibb. Bristol Myers Squibb.
3. Fedratinib Market Size and Projections - Market Research Intellect. Market Research Intellect.
4. Multi-Discipline Review - accessdata.fda.gov. FDA.
5. INREBIC Drug Patent Profile - DrugPatentWatch. DrugPatentWatch.