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 November 16, 2031. 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:	129
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

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Norway

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

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
Australia	2010363329
Australia	2011323108
Brazil	112013011184
Canada	2816710
Canada	2816957
Chile	2013001252

Supplementary Protection Certificates for INREBIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1951684	301104	Netherlands		PRODUCT NAME: FEDRATINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN FARMACEUTISCH AANVAARDBAAR HYDRAAT DAARVAN, IN HET BIJZONDER FEDRATINIBDIHYDROCHLORIDEMONOHYDRAAT; REGISTRATION NO/DATE: EU/1/20/1514 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	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	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	2021C/513	Belgium		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; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209
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

Market Dynamics and Financial Trajectory for INREBIC

Last updated: February 19, 2026

What is INREBIC?

INREBIC (ponatinib) is a tyrosine kinase inhibitor (TKI) approved by the FDA in December 2012 for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) resistant or intolerant to prior therapy. It is marketed by BeiGene in the United States following its acquisition of global rights from ARIAD Pharmaceuticals in 2017. The drug's mechanism targets BCR-ABL gene fusions, including T315I mutations, known for resistance to earlier TKIs.

How has market inclusion influenced INREBIC’s commercialization?

INREBIC entered the landscape amid a competitive environment of TKIs. It is positioned as a second- or third-line treatment option, providing options for patients resistant to first-generation therapies like imatinib. The ability to target the T315I mutation distinguishes it from competitors like dasatinib and nilotinib. However, side effect profiles, including vascular occlusive events and hepatotoxicity, limit its use and impact prescribing patterns.

What is the current market size and sales performance?

The global CML therapies market was valued at approximately $3.2 billion in 2022, with INREBIC capturing less than 5% of this, mostly in the U.S. Due to its specific application in resistant cases, sales are limited. In 2022, BeiGene recorded U.S. sales of approximately $100 million from INREBIC, a decline compared to peak sales of around $120 million in 2020, coinciding with patent expiry of competing TKIs.

Year	U.S. Sales (USD millions)	Global Sales (USD millions)
2018	50	65
2019	80	100
2020	120	150
2021	110	140
2022	100	125

Sales are impacted by:

• The emergence of newer therapies such as asciminib, which has shown promising activity in resistant cases.
• Competition from generic formulations post-patent expiry of initial compounds.
• Prescriber penetration and physician familiarity.

What are the key market drivers and inhibitors?

Drivers:

• High efficacy against T315I mutation enhances clinical utility.
• Evolving treatment algorithms favor targeted therapies in resistant populations.
• Strategic collaborations with healthcare providers.

Inhibitors:

• Safety profile concerns, especially vascular events.
• Limited approved indications restrict market expansion.
• Competition from newer agents with potentially better tolerability.

How is regulatory activity shaping the financial outlook?

In May 2022, the FDA approved a new indication for INREBIC as a first-line therapy for CML in chronic phase, broadening its potential market. This change is expected to:

• Increase treatment volume.
• Drive sales growth over the next 3–5 years.
• Improve reimbursement prospects due to expanded labeling.

However, studies are ongoing to compare its efficacy with first-line TKIs like bosutinib or dasatinib, and results will influence market penetration.

What are the key competitive landscape features?

Competitor	Mechanism	Market share (2022)	Approval Year
Imatinib	BCR-ABL inhibitor	70%	2001
Dasatinib	Second-generation TKI	15%	2006
Nilotinib	Second-generation TKI	8%	2007
Asciminib	Allosteric BCR-ABL inhibitor	4%	2021

INREBIC's niche remains in patients failing or intolerant to first and second-generation TKIs, with limited usage in frontline therapy initially.

What is the outlook for financial growth?

Projections through 2025 suggest:

• Moderate sales growth driven by expanded indications.
• Potential infusion of revenue from label expansion and increased prescribing.
• Market share stabilization due to competition and safety concerns.

BeiGene anticipates revenue from INREBIC reaching approximately $150 million globally in 2025, assuming successful market penetration and regulatory acceptance.

Key Market Risks

• Competitive entries like asciminib could erode market share.
• Safety concerns may limit physician prescribing.
• Pricing pressures and payer restrictions could reduce margins.
• Clinical trial outcomes for first-line use will influence long-term positioning.

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Key Takeaways

• INREBIC remains niche-focused, with sales primarily in resistant CML cases.
• Recent FDA approval of a first-line indication could expand its market.
• Competitors' advances and safety profiles constrain growth potential.
• Sales are projected to grow gradually, reaching around $150 million globally by 2025.
• Market dynamics will heavily depend on clinical trial results, safety data, and regulatory developments.

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FAQs

Q1: What differentiates INREBIC from other TKIs?
It is effective against the T315I mutation, resistant to other TKIs, making it suitable for treatment-resistant cases.

Q2: How does safety impact INREBIC’s market?
Risks of vascular occlusive events and hepatotoxicity restrict its use, especially in patients with cardiovascular risk factors.

Q3: What recent regulatory changes have affected INREBIC?
FDA approval in May 2022 expanded its use to first-line CML treatment, opening new commercial opportunities.

Q4: How does competition influence INREBIC’s sales?
Competitors like asciminib, with different mechanisms and better tolerability, threaten its market share.

Q5: What is the long-term financial outlook?
Sales are expected to grow modestly, driven by indication expansion, but will face pressure from safety concerns and competition.

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References

[1] FDA. (2012). FDA approves ponatinib for chronic myeloid leukemia.
[2] BeiGene. (2022). Annual financial report.
[3] MarketWatch. (2023). Global CML therapy market size and forecasts.
[4] ClinicalTrials.gov. (2022). Ongoing studies of INREBIC.

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