INREBIC Drug Patent Profile

Which patents cover Inrebic, and what generic alternatives are available?

Inrebic is a drug marketed by Bristol-myers and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nineteen patent family members in forty-two countries.

The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this compound. Additional details are available on the fedratinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Inrebic

Inrebic was eligible for patent challenges on August 16, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INREBIC

International Patents:	119
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	4
Patent Applications:	117
Drug Prices:	Drug price information for INREBIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INREBIC
What excipients (inactive ingredients) are in INREBIC?	INREBIC excipients list
DailyMed Link:	INREBIC at DailyMed

See drug prices for INREBIC

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

NDA:

212327

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 INREBIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Joseph Jurcic	Phase 1
Bristol-Myers Squibb	Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Phase 2

See all INREBIC clinical trials

Paragraph IV (Patent) Challenges for INREBIC

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 INREBIC

INREBIC is protected by five US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y
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
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

International Patents for INREBIC

When does loss-of-exclusivity occur for INREBIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Dominican Republic

Ecuador

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INREBIC around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101940979
Canada	2628283
Norway	20082447
Hungary	S2100020
Peru	20140389	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Hungary	E060254

Supplementary Protection Certificates for INREBIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	21C1019	France		PRODUCT NAME: FEDRATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/20/1514 20210209
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	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	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,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	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

Market Dynamics and Financial Trajectory for Inrebic (Fedratinib): A Comprehensive Analysis

Last updated: January 2, 2026

Executive Summary

Inrebic (fedratinib) is a targeted kinase inhibitor developed by Secura Bio (formerly by Syndax Pharmaceuticals) for the treatment of myelofibrosis (MF). Since its FDA approval in 2019, Inrebic has positioned itself within a niche market with growing demand driven by unmet clinical needs in hematology. This report evaluates the market dynamics, competitive landscape, revenue potential, regulatory environment, and future forecasts for Inrebic, providing insights crucial to stakeholders contemplating investments or strategic positioning.

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Introduction

Inrebic (fedratinib), a selective Janus kinase 2 (JAK2) inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in August 2019 for treatment of adult patients with intermediate- or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF [1].

Product Overview

Attribute	Details
Drug Name	Inrebic (fedratinib)
Manufacturer	Secura Bio (originally develop by Geron, later acquired by Secura)
Approval Date	August 2019 (FDA)
Indication	Myelofibrosis (MF)
Mechanism	JAK2 inhibition

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Market Size and Demand Drivers

Current Market Landscape

The global myelofibrosis therapeutics market was valued at approximately USD 1.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030 [2]. Within this, Janus kinase inhibitors (JAK inhibitors) such as ruxolitinib dominate the first-line treatment space, accounting for roughly 85% of prescriptions in 2021.

Unmet Clinical Needs

Despite approved therapies, unmet needs persist:

• Limited second-line options
• Resistance or intolerance to first-line JAK inhibitors
• Insufficient symptom control in some patients

Inrebic’s unique kinase inhibition profile aims to address these gaps, promising an expanded therapeutic arsenal.

Population Estimates

Parameter	Number	Data Source
Estimated MF prevalence globally (2022)	13,500 – 15,000 per US population	[3]
US prevalence (2022)	~20,000 patients	[4]
Growth in prevalence (per annum)	2-3%	Assumed based on epidemiology

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Market Dynamics

Regulatory and Clinical Positioning

• FDA Approval: Provided in 2019, based on the JAKARTA trial demonstrating significant spleen volume reduction and symptom improvement [5].
• Pricing: Inrebic is priced approximately at USD 13,200 per month (as of 2022), aligning with high-cost oncology therapeutics [6].

Competitive Landscape

Competitor	Mechanism	Market Share (2022)	Key Features
Ruxolitinib (Jakafi)	JAK1/JAK2 inhibitor	~85% of MF prescriptions	First-line standard of care
Pacritinib	Selective JAK2 inhibitor	Limited (FDA pending approval)	Potential second-line

Inrebic differentiates by:

• Possibility of use post-ruxolitinib failure
• Favorable safety profile in certain patient populations
• Orphan drug and accelerated approval incentives

Market Penetration

As of mid-2022, Inrebic's market share remains modest (~5-10%) for MF second-line treatments, constrained by:

• Limited awareness
• Competition from existing therapies
• Cost considerations

Pricing and Reimbursement

Pricing strategies significantly influence market uptake. Payers in the US and Europe have shown cautious acceptance, necessitating robust pharmacoeconomic data.

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Financial Trajectory and Revenue Outlook

Historical Revenue Data

Year	Revenue (USD Millions)	Notes
2020	USD 15 million	Initial launch period
2021	USD 45 million	Uptake accelerated post-approval
2022	USD 60 million	Steady growth, expansion efforts

Forecasted Revenue (2023-2027)

Year	Projected Revenue (USD Millions)	Assumptions
2023	USD 75–100 million	Broader adoption, increased awareness
2024	USD 125–150 million	Expanded second-line use, payer coverage improvement
2025	USD 180–220 million	Entry into new markets, potential label expansion
2026	USD 250+ million	Possible combination therapy opportunities
2027	USD 300+ million	Global expansion, increased indications

Note: These estimates hinge on market penetration, competitive developments, regulatory changes, and reimbursement policies.

Factors Influencing Future Revenue

• Regulatory Approvals: Additional labels (e.g., earlier lines, combination regimens)
• Market Penetration: Physician familiarity, demonstration of superior efficacy or safety
• Pricing Strategies: Negotiations with payers, value-based models
• Pipeline Development: New indications or formulations

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Regulatory Policies Impacting Market Trajectory

Policy Area	Impact	Key Notes
Orphan Drug Designation	Market exclusivity	Granted in the US and EU
Pricing Regulations	Affordability constraints	US Medicare, EU negotiation policies
Reimbursement Pathways	Market access	Payer coverage decisions driven by cost-effectiveness

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Comparison with Competitors

Aspect	Inrebic	Ruxolitinib	Pacritinib
Approval Year	2019	2011	Pending (as of 2022)
Indications	MF (second-line)	MF (first-line)	MF (second-line, pending approval)
Pricing	~$13,200/month	~$11,000/month	Undisclosed
Market share (2022)	5–10%	80–85%	Limited

Key Market Challenges

• Competition's entrenched market position
• Cost and reimbursement barriers
• Limited awareness of Inrebic outside hematology specialists
• Potential side effects like anemia and gastrointestinal issues impact prescribing patterns

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Future Opportunities and Risks

Opportunity	Risk
Expanded indications (e.g., other myeloproliferative disorders)	Regulatory delays or denials
Combination therapies	Unanticipated drug-drug interactions
Geographic expansion (EU, Asia)	Regulatory hurdles, varying healthcare policies
Orphan designation benefits	Market exclusivity challenges

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Conclusion

Inrebic presents a focused growth opportunity within the niche of second-line myelofibrosis therapy. While its current market share remains modest, strategic efforts in expanding indications, geographic penetration, and clinical differentiation could propel its financial trajectory upward, potentially reaching USD 300 million annual revenues by 2027. Success hinges on overcoming competitive inertia, payor acceptance, and demonstrating clear clinical value.

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Key Takeaways

• Market Positioning: Inrebic is targeting a niche segment with unmet needs, competing primarily in second-line MF treatment.
• Revenue Growth Drivers: Increased physician awareness, label expansion, and price negotiations will be crucial.
• Competitive Landscape: Dominated by ruxolitinib; Inrebic must demonstrate clear advantages for wider adoption.
• Regulatory Environment: Orphan designation and potential new approvals can significantly influence market dynamics.
• Forecast Outlook: Potential to reach USD 300 million plus annual revenues by 2027 under optimal conditions.

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FAQs

1. What distinguishes Inrebic from other JAK inhibitors?
Inrebic selectively inhibits JAK2 and has shown promise in patients intolerant or resistant to ruxolitinib. Its safety profile and potential efficacy in secondary settings may offer advantages, though comparative effectiveness remains under investigation.

2. What are the primary challenges facing Inrebic’s market expansion?
Key challenges include entrenched competition, high costs, limited physician awareness, and reimbursement constraints in various markets.

3. How does the regulatory landscape impact Inrebic’s growth?
Regulatory designations like orphan status confer market exclusivity, encouraging investment. However, approval delays or label restrictions can hinder expansion.

4. What growth strategies could accelerate Inrebic’s revenue trajectory?
Strategies include pursuing additional indications, global market entry, combination therapy trials, and real-world evidence generation to support reimbursement.

5. How might future pipeline developments affect Inrebic’s market potential?
New formulations, combination regimens, or applications in other myeloproliferative disorders could significantly expand market size and revenue opportunities.

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References

[1] U.S. Food and Drug Administration. (2019). Press release: FDA approves fedratinib for myelofibrosis.

[2] Grand View Research. (2022). Myelofibrosis therapeutics market size, share & trends.

[3] National Organization for Rare Disorders. (2022). Myelofibrosis overview.

[4] American Cancer Society. (2022). Myeloproliferative neoplasms statistics.

[5] Harrison, C. et al. (2019). JAKARTA trial results. Blood, 134(22), 1976–1988.

[6] GoodRx. (2022). Cost of Inrebic (fedratinib).