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 seventeen 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:	117
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

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
Taiwan	I531389
Israel	191167
Canada	2816957	COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)

Supplementary Protection Certificates for INREBIC

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

Market Dynamics and Financial Trajectory for Inrebic (Fedratinib)

Last updated: July 27, 2025

Introduction

Inrebic (fedratinib) is an oral Janus kinase 2 (JAK2) inhibitor developed by Celgene (now part of Bristol-Myers Squibb following a 2019 acquisition). Approved by the U.S. Food and Drug Administration (FDA) in August 2019 for treatment of intermediate- or high-risk myelofibrosis (MF), Inrebic has positioned itself within the niche of targeted therapies for myeloproliferative neoplasms (MPNs). The drug’s market dynamics are shaped by its clinical efficacy, competitive landscape, regulatory environment, and evolving healthcare strategies, which collectively chart its financial trajectory.

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Market Landscape for Myeloproliferative Neoplasms

Myelofibrosis represents a rare, yet impactful, hematologic malignancy characterized by fibrosis of the bone marrow, cytopenias, and splenomegaly, often leading to poor prognosis. The disease's prevalence rates are approximately 1.5-2.5 cases per 100,000 individuals globally, with higher incidence in older populations ([3]). The overall unmet need and limited therapeutic options make this segment attractive for targeted kinase inhibitors like Inrebic.

The global myelofibrosis market was valued at approximately USD 200 million in 2020, with projections to reach USD 300-400 million by the late 2020s, driven by increasing diagnosis rates and novel treatment options ([4]). The critical competitors include Jakafi (ruxolitinib, Novartis), the first JAK1/JAK2 inhibitor approved in 2011, which retains a dominant market share, and emerging therapies like Pacritinib and other novel agents.

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Market Dynamics Influencing Inrebic

1. Clinical Differentiation and Therapeutic Positioning

Inrebic’s approval was based on the JAKARTA2 trial demonstrating meaningful spleen reduction and symptom improvement in MF patients, especially those intolerant or resistant to ruxolitinib ([1]). Its specificity for JAK2 offers a potential advantage, although the limited head-to-head data versus Jakafi constrains clinical positioning.

2. Regulatory and Reimbursement Factors

Post-approval, Inrebic faced initial cautious adoption due to safety concerns such as gastrointestinal toxicities and anemia, which require careful management. The drug’s reimbursement landscape hinges on its perceived value relative to Jakafi and emerging competitors, influenced by pricing strategies and negotiations with payers.

3. Competitive Landscape and Market Share

Jakafi, holding approximately 80% of the market, established a dominant position, with sales exceeding USD 1.5 billion in 2021 ([5]). Inrebic’s market penetration remains limited but is expected to grow as clinicians seek alternatives for patients intolerant to ruxolitinib. Early adoption has been incremental, hindered by safety profiles and clinical familiarity.

4. Pipeline and Future Indications

Additional approvals for related indications, such as treatment of polycythemia vera or essential thrombocythemia, could broaden Inrebic’s indications, augmenting its market potential. Ongoing clinical trials aim to establish these uses, with positive results potentially enhancing revenue streams.

5. Pricing and Market Access Strategies

Inrebic’s pricing, aligned with rival therapies, is crucial for adoption. Optimized access and demonstrating clinical benefits over competitors will be pivotal. Value-based pricing models could enhance financial uptake and market share.

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Financial Trajectory

Current Revenue Performance

Inrebic’s sales trajectory remains modest, with initial sales figures estimated at USD 50-75 million in 2020, reflecting early-stage market acceptance. Revenues increased modestly in subsequent quarters with wider clinician familiarity and expanded indications.

Growth Drivers

• Expanding Indications: Approval for additional MPNs could substantially increase prescriptions.
• Competitive Differentiation: Demonstrating superior efficacy or safety advantages enhances adoption.
• Market Penetration: Increasing awareness and physician familiarity, especially among ruxolitinib-resistant patients.
• Pricing Strategies: Value-based negotiations with payers could bolster revenue.

Risks and Challenges

• Market Dominance of Jakafi: Overcoming Jakafi’s entrenched market position remains difficult.
• Safety and Tolerability Issues: Managing adverse events will influence prescribing patterns.
• Pipeline Uncertainties: Success of clinical trials for new indications determines future growth.

Forecast Outlook (2023-2028)

Analysts project Inrebic’s sales could reach USD 200-350 million within five years if it successfully gains share among MF patients resistant or intolerant to Jakafi. A compounded annual growth rate (CAGR) of approximately 10-15% is plausible, contingent upon regulatory approvals, clinical successes, and market acceptance.

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Key Market Drivers & Constraints

Drivers	Constraints
Growing MF patient population	Entrenched Jakafi market leader
Broadened indications	Safety/tolerability concerns
Enhanced clinician awareness	Competitive pipeline threats
Payer acceptance of value	Limited real-world data for Inrebic

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Strategic Recommendations

• Clinical Differentiation: Conduct head-to-head trials comparing Inrebic with Jakafi to establish clear advantages.
• Pipeline Expansion: Explore approvals for other MPNs to diversify revenue streams.
• Market Access Optimization: Develop flexible pricing and reimbursement strategies aligned with healthcare system needs.
• Patient-Centric Approaches: Focus on safety and tolerability improvements to address unmet clinical needs.

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Conclusion

Inrebic’s market and financial prospects hinge on its ability to carve out a niche within the established MF treatment paradigm dominated by Jakafi. While current revenues are modest, strategic clinical and commercial initiatives could significantly enhance its trajectory. Success depends on differentiation through efficacy and safety, expanded indications, competitive pricing, and clinician engagement. The drug’s future remains promising should it effectively address existing market gaps and leverage emerging opportunities in MPN management.

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Key Takeaways

• Market Potential: The myelofibrosis market offers growth opportunities, particularly for therapies targeting resistant or intolerant patients.
• Competitive Positioning: Inrebic must differentiate itself from Jakafi through clinical advantages and expanded indications.
• Revenue Forecast: Projected to reach USD 200-350 million within five years with strategic market expansion.
• Challenges: Entrenched competitors, safety profile considerations, and pipeline uncertainties remain significant hurdles.
• Opportunities: Clinical trials for additional indications and payer strategies could catalyze growth.

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FAQs

Q1: How does Inrebic compare to Jakafi in clinical efficacy?
Inrebic demonstrates significant spleen reduction in certain MF patient subsets, especially those resistant or intolerant to Jakafi. However, direct comparative trials are limited, making clinical distinctions reliant on individual trial data.

Q2: What are the main safety concerns associated with Inrebic?
Gastrointestinal toxicities, including nausea and diarrhea, along with hematologic adverse events like anemia, are notable safety considerations impacting patient management.

Q3: Are there plans to expand Inrebic’s indications?
Yes. Ongoing clinical trials aim to evaluate Inrebic for polycythemia vera and essential thrombocythemia, potentially broadening its market footprint.

Q4: How significant is the patent landscape for Inrebic?
Patent protection extends into the mid-2020s, providing exclusivity in key markets, though competition from generics post-patent expiry could impact future revenues.

Q5: What strategies could enhance Inrebic’s market penetration?
Developing head-to-head comparative data, expanding indications, optimizing payer agreements, and improving safety profiles will be critical to increase adoption in a competitive environment.