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 seventeen patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for FEDRATINIB HYDROCHLORIDE

International Patents:	117
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	23
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
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	11,400,092
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327-001	Aug 16, 2019		RX	Yes	Yes	10,391,094		Y
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	7,528,143		Y	Y

International Patents for FEDRATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I531389
Israel	191167
Canada	2816957	COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Lithuania	PA2021509
Russian Federation	2448959
Japan	2013541595

Supplementary Protection Certificates for FEDRATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	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	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

Market Dynamics and Financial Trajectory for Fedratinib Hydrochloride

Last updated: July 29, 2025

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Introduction

Fedratinib Hydrochloride represents a significant advancement in the treatment landscape of myelofibrosis (MF), a rare but serious bone marrow disorder characterized by scarring that impairs blood cell production. As a selective JAK2 inhibitor, Fedratinib offers a targeted approach, addressing unmet needs for patients refractory to existing therapies. This analysis delineates the evolving market dynamics and projects the financial trajectory of Fedratinib Hydrochloride, considering recent developments, competitive forces, regulatory pathways, and commercial strategies.

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Market Landscape and Therapeutic Positioning

Unmet Medical Need in Myelofibrosis

Myelofibrosis, a subtype of myeloproliferative neoplasms, affects approximately 2.8 per 100,000 individuals globally, with higher prevalence among the elderly. Current first-line treatment options primarily include Janus kinase (JAK) inhibitors such as ruxolitinib and fedratinib (marketed as Inrebic in the U.S.), which improve symptoms and spleen size but do not cure the disease. Resistance, intolerance, or suboptimal responses necessitate alternative therapies.

Fedratinib’s Competitive Edge

Fedratinib’s selectivity for JAK2, along with its unique pharmacokinetics, positions it as a promising second-line agent or alternative for patients intolerant to ruxolitinib. Its approval by the FDA in 2019 and subsequent global regulatory authorizations underscore its clinical significance. The drug's ability to demonstrate durable responses in clinical trials underscores its potential to capture significant market share.

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Market Dynamics

Regulatory and Reimbursement Environment

Post-approval, the trajectory of Fedratinib’s market penetration hinges on favorable reimbursement policies and broad clinician acceptance. Regulatory agencies such as the FDA and EMA have set precedents for expedited review processes given its addressal of high unmet needs. Insurance coverage and payer acceptance will critically influence prescribing patterns.

Manufacturing and Supply Chain

The production scale-up is pivotal to meet forecasted demand. As a synthetic small molecule, Fedratinib benefits from terrestrial manufacturing efficiencies; however, ensuring consistent quality and reducing costs remain paramount for profitability.

Competitive Landscape

The market features limited competition; ruxolitinib dominates the front-line, with emerging agents and pipeline drugs seeking niche indications or combination strategies. Imago Biosciences’ momelotinib, another JAK inhibitor, and potential innovative therapies like pacritinib present competitive challenges. Personalized treatment algorithms and biomarker-driven approaches may delineate market segments.

Market Penetration and Adoption Drivers

Physician familiarity, patient preference for oral agents, and real-world safety profile influence adoption. Education campaigns, clinical guideline endorsements, and post-marketing studies will expedite prescribing practices.

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Financial Trajectory

Revenue Projections

Forecasting revenue involves assessing market size, penetration rate, pricing strategy, and competitive positioning. For Fedratinib, initial sales are expected predominantly in North America, with subsequent expansion into Europe and Asia-Pacific.

Assuming conservative penetration of 10% of the estimated 10,000 eligible patients across North America by Year 3, with an average annual treatment cost of $150,000, revenues could approximate $150 million annually. Globally, with escalation and expanded indication approvals, revenues could approach $300-500 million by Year 5.

Pricing Strategy and Market Share

Pricing hinges on comparative efficacy and safety profiles. Given its niche positioning, premium pricing may be feasible, especially if it demonstrates superior tolerance or efficacy in specific patient subsets.

Market share growth will depend on clinical acceptance, reimbursement prices, and the robustness of ongoing real-world evidence. Substantial patent life and exclusivity rights bolster revenue longevity.

Cost Structure and Margins

Research and development (R&D) costs, predominantly incurred pre-approval, are amortized over time. Commercial operations, manufacturing, and distribution expenses impact gross margins. Optimizing these parameters through strategic manufacturing partnerships and scalable operations enhances profitability.

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Emerging Trends and Future Outlook

Pipeline and Adjunctive Therapies

Ongoing clinical trials exploring Fedratinib in combination with other agents could enhance effectiveness and expand indications. These strategies may influence long-term market share and revenue potential.

Global Access and Socioeconomic Factors

Patent expirations, biosimilar competition, and pricing pressures may impact profit margins over the next decade. Conversely, expanding into emerging markets with tailored pricing models offers revenue opportunities.

Regulatory Developments and Market Entry Barriers

Potential approval of Fedratinib for other indications, such as polycythemia vera, can diversify its revenue base. Regulatory delays or safety concerns could hinder growth; hence, robust pharmacovigilance and data transparency are critical.

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Key Challenges & Risks

• Safety Profile and Adverse Events: Warnings such as Wernicke's encephalopathy, observed in post-marketing surveillance, pose risks of market restrictions.
• Market Competition: Rapid innovation and pipeline entrants can erode market share.
• Reimbursement Hurdles: Payer resistance or delays in formulary listing impact commercialization timelines.
• Pricing Pressures: Health technology assessments may impose cost constraints affecting profitability.

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Conclusion

Fedratinib Hydrochloride’s market potential is significant within the niche of therapeutic options for myelofibrosis. Its financial trajectory depends on strategic positioning, global regulatory acceptance, competitive landscape navigation, and effective commercialization strategies. While early indications point to a promising growth path, ongoing clinical validation and market adaptation remain vital to maximizing its economic impact.

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Key Takeaways

• Market Demand: Rising prevalence of myelofibrosis and unmet needs underpin Fedratinib’s substantial market potential.
• Competitive Position: Its targeted mechanism and favorable safety profile can facilitate rapid adoption among clinicians.
• Revenue Potential: Estimated revenues could reach hundreds of millions within five years, contingent on market access and reimbursement.
• Strategic Factors: Effective supply chain management, clinician education, and post-market data will be crucial for sustained growth.
• Future Growth: Expansion into new indications and geographic markets can further enhance long-term financial prospects.

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FAQs

1. What is Fedratinib Hydrochloride approved for?
Fedratinib is FDA-approved for treating intermediate- to high-risk myelofibrosis in adults, especially in cases where patients are resistant or intolerant to ruxolitinib.

2. How does Fedratinib differ from other JAK inhibitors?
Fedratinib exhibits high selectivity for JAK2, potentially translating into fewer off-target effects and a different safety profile compared to less selective inhibitors like ruxolitinib.

3. What are the key market risks for Fedratinib?
Safety concerns, comparator drugs entering the market, reimbursement challenges, and patent expirations could impact its market share.

4. Can Fedratinib be used in other diseases?
Currently approved for myelofibrosis, ongoing trials are exploring its efficacy in other myeloproliferative neoplasms, which could expand its indications.

5. What strategies can maximize Fedratinib’s market penetration?
Educating clinicians, securing payer coverage, expanding geographic reach, and demonstrating real-world benefits are critical strategies for growth.

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Sources

[1] National Cancer Institute. Myelofibrosis Statistics.
[2] U.S. Food and Drug Administration. Fedratinib (Inrebic) Approval and Labeling.
[3] GlobalData Pharma Intelligence. Market Forecast for JAK Inhibitors.
[4] ClinicalTrials.gov. Ongoing Trials with Fedratinib.