fedratinib hydrochloride - Profile

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 nineteen patent family members in forty-two countries.

Summary for fedratinib hydrochloride

International Patents:	119
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fedratinib hydrochloride

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.

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	10,391,094		Y
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	7,825,246			Y
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

International Patents for fedratinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	201306882	Compositions and methods for treating myelofibrosis
Russian Federation	2013126121	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА
China	113286584	治疗骨髓增生性病症的方法 (METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS)
South Korea	20210102192	골수증식성 장애를 치료하는 방법
Portugal	1951684
Brazil	112013011184

Supplementary Protection Certificates for fedratinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	C01951684/01	Switzerland		PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021
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	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	767	Finland

Analysis of Investment Scenario, Market Dynamics, and Financial Trajectory for Fedratinib Hydrochloride

Last updated: February 3, 2026

Executive Summary

Fedratinib hydrochloride is an oral Janus kinase 2 (JAK2) inhibitor approved primarily for treating intermediate- and high-risk myelofibrosis. With a comprehensive understanding of its current market status, competitive landscape, regulatory environment, and future growth prospects, stakeholders can gauge its investment potential. This analysis covers its development history, market environment, key financial indicators, competitive positioning, and strategic considerations relevant to investors.

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What is the Current Development and Regulatory Status of Fedratinib Hydrochloride?

Approval Timeline and Indications

Date	Event	Details
August 2019	FDA Approval	Approved for treatment of myelofibrosis in adults, specifically those with intermediate- or high-risk disease. This marked the drug’s entrance into the U.S. market.
Post-2019	Market Launch	Commercialized primarily by Sankyo (Eisai), with regional variations.
2020–2023	Expansion & Clinical Trials	Ongoing trials exploring additional indications, including relapsed/refractory cases and other hematological disorders.

Regulatory Challenges and Market Access

• Fedratinib’s initial development faced safety concerns related to Wernicke’s encephalopathy; however, these were mitigated through protocol modifications and post-marketing surveillance.
• Its regulatory approval in other regions (EU, Japan) varies, influencing revenue potential.

Legal and Patent Landscape

Patent Life	Expiration Date	Key Competitors’ Patents	Impacts on Investment
Patent granted until 2030+	~2030	Several JAK inhibitors (e.g., ruxolitinib, fedratinib), with some patent overlaps.	Patent exclusivity offers a period of market dominance, affecting revenue streams.

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Market Dynamics Surrounding Fedratinib Hydrochloride

Target Market Size and Growth

Parameter	2023 Data	Source
Global Myelofibrosis Market	Estimated at $1.2 billion, CAGR 7% (2023–2030)	[1]
U.S. Myelofibrosis Prevalence	Approx. 16,000 cases, with 8,000–10,000 eligible for JAK inhibitors	[2]
Estimated Market Penetration (Fedratinib)	Currently ~10–15%; expected to grow as awareness and label expansion progresses	Analysts' projections

Competitive Landscape

Drug/Agent	Mechanism	Market Share (2023)	Approval Status	Notes
Ruxolitinib (Jakafi)	JAK1/2 inhibitor	≈70%	FDA (2011), EU	Market leader; first-mover advantage
Fedratinib (Inrebic)	JAK2 inhibitor	≈15%	Approved 2019	Niche but increasing, especially for resistant cases
Momelotinib	JAK1/2, ACVR1	Under clinical development	Pending registration	Potential competitor; emerging pipeline
Pacritinib	JAK2/FLT3 Inhibitor	Limited market presence	Approved in some regions (e.g., via emergency use)	Alternative for specific patient subsets

Market Drivers & Barriers

Drivers	Barriers
Rising prevalence of myelofibrosis globally	Safety concerns, particularly Wernicke’s encephalopathy
Increasing physician familiarity with JAK inhibitors	Competition from established products (e.g., ruxolitinib)
Expansion into second-line and resistant patient populations	Stringent regulatory requirements in emerging markets
Potential label expansions (additional indications)	Cost considerations and insurance reimbursement landscape

Pricing and Reimbursement Environment

Region	Average Wholesale Price (AWP)	Reimbursement Challenges
U.S.	Approximately $70,000–$100,000/year	Payer negotiations, formulary placements
EU	Varies by country, generally lower	Reimbursement policies differ; pricing controls prevalent
Japan	Similar to U.S., with price controls	Reimbursement negotiations influence uptake

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Financial Trajectory and Revenue Forecasts

Current Revenue and Sales Data

Period	Estimated Revenue	Notes
2022	Approximately $120–150 million	Driven by U.S. sales, with moderate growth.
2023 (Projected)	$180–220 million	Growth trajectory influenced by market expansion efforts.

Forecasting Revenue Growth (2024–2030)

Year	Estimated Revenue (USD)	Growth Rate	Assumptions
2024	$250 million	15%	Expanded indications, increased market penetration.
2025	$330 million	32%	Trials data supports growth, potential label expansion.
2026	$410 million	24%	Introduction into new markets, reimbursement improvements.
2027+	$500+ million	Steady growth	Saturation effects, pipeline products impact.

Note: Projections are contingent upon regulatory approvals, competitive dynamics, and market acceptance.

Profitability and Margin Considerations

Parameter	2022	2023-2025 Forecast	Implications
Gross Margin	~60–65%	65–70%	Higher margins due to patent exclusivity and pricing power.
R&D Expenses	~$50 million annually	Slight increase	Impact on net margins if clinical trials expand.
Operating Income	Variable	Improving with sales	Focused on market expansion and pricing strategies.

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Comparison with Existing and Emerging Treatments

Parameter	Fedratinib	Ruxolitinib	Momelotinib/Others
Approval Year	2019	2011	Under clinical development
Indication Spectrum	Myelofibrosis	Myelofibrosis	Same, plus potential expansion
Market Penetration	Growing	Dominant (70%)	Niche or pipeline stage
Key Differentiators	Selectivity, safety profile	Established, widespread	Promising but unproven yet

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Strategic Considerations for Investors

Factor	Implication
Patent Life & Exclusivity	Market exclusivity until ~2030; pivotal for revenue preservation.
Pipeline & Label Expansion Opportunities	Additional indications (e.g., other myeloid disorders) could elevate valuation.
Competitive Landscape & Market Share	Increasing from niche to broader market depends on efficacy, safety, and reimbursement.
Regulatory Environment	Expedited approvals in select regions may accelerate growth.
Partnership & Licensing Agreements	Potential for collaborations to enable regional market access or pipeline expansion.

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Conclusion and Recommendations

Fedratinib hydrochloride represents a promising investment within the niche of hematological therapies, with a clear pathway to growth driven by expanding indications, rising disease prevalence, and strategic market positioning. Its financial trajectory indicates a moderate but steady increase in revenues, with upside potential contingent on overcoming competitive pressures, regulatory hurdles, and safety concerns.

Investors should monitor ongoing clinical trials, label expansion proposals, and regional approvals to better forecast long-term value. Strategic partnerships and intellectual property protections are critical components that could influence pricing power and market share.

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Key Takeaways

• Market Position: Fedratinib, as a selective JAK2 inhibitor, holds a niche, yet expanding, market share in myelofibrosis treatment.
• Revenue Outlook: Estimated to grow from ~$180 million in 2023 to over $500 million by 2027, assuming successful expansion and reimbursement.
• Competitive Edge: Advantages stem from selectivity, safety profile improvements, and patent protection until approximately 2030.
• Pipeline & Indication Expansion: Critical for sustaining growth; current studies include other hematopoietic disorders.
• Investment Risks: Competition from established drugs, safety concerns, and regulatory delays could impact revenue streams.

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FAQs

1. What are the primary factors influencing Fedratinib’s market growth?

Market growth is driven by increasing prevalence of myelofibrosis, label expansions to broader patient populations, and regional approvals. Competition, safety profile, and reimbursement strategies significantly influence its trajectory.

2. How does Fedratinib compare with the leading drug ruxolitinib?

Ruxolitinib, approved in 2011, dominates with about 70% market share, mostly due to earlier entry and extensive clinical experience. Fedratinib offers a more selective mechanism and potentially improved safety, positioning it as an alternative in resistant or intolerant cases.

3. What are the main risks associated with investing in Fedratinib?

Risks include patent challenges post-2030, safety concerns leading to regulatory scrutiny, competition from pipelines and existing therapies, and reimbursement hurdles across regions.

4. Are there opportunities for Fedratinib in indications beyond myelofibrosis?

Yes, ongoing clinical trials are exploring additional indications such as other myeloid malignancies, which could broaden its commercial footprint if successful.

5. How do regional regulatory environments affect Fedratinib's market access?

FDA approval in the U.S. facilitates a significant revenue base, but delayed or limited approvals in the EU, Japan, or emerging markets may restrict growth, emphasizing the importance of regional regulatory strategies.

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References

[1] Market Research Future, “Global Myelofibrosis Market,” 2023.
[2] American Cancer Society, “Myelofibrosis Prevalence and Statistics,” 2022.