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INREBIC Drug Patent Profile

When do Inrebic patents expire, 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 ten patent family members in forty 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for INREBIC

International Patents:	110
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	4
Patent Applications:	352
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 two FDA Regulatory Exclusivities.

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
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

Poland

Portugal

Russian Federation

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
Hungary	E028987
South Korea	20080066066	BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES
Canada	2816957	COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
New Zealand	567851	Bi-aryl meta-pyrimidine inhibitors of kinases
Dominican Republic	P2013000097	COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Lithuania	1951684
Spain	2930650

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	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	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
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	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
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

INREBIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inrebic

Introduction

Inrebic, also known as fedratinib, is a Janus kinase (JAK) inhibitor approved by the FDA for the treatment of myelofibrosis, a rare and serious bone marrow disorder. Here, we delve into the market dynamics and financial trajectory of Inrebic, highlighting its development, approval, and market performance.

Development and Approval

Inrebic's journey to approval was marked by several challenges. Initially developed by TargeGen, the drug was later acquired by Sanofi, which halted clinical trials in 2013 due to an FDA hold. Celgene revived the project through its $1.1 billion acquisition of Impact Biomedicines in 2018. The FDA approved Inrebic in August 2019, making it the first new treatment for myelofibrosis in nearly a decade[1][4].

Market Authorization and Clinical Benefits

The approval of Inrebic was based on data from two pivotal trials: the Phase III JAKARTA trial and the Phase II JAKARTA-2 study. These trials demonstrated significant clinical benefits, including spleen volume reduction and total symptom score reduction in patients with intermediate-2 or high-risk primary myelofibrosis and secondary myelofibrosis[3].

Market Positioning

Inrebic enters a market dominated by other JAK inhibitors, such as Incyte's Jakafi (ruxolitinib) and more recently approved drugs like Ojjaara (momelotinib). Despite being a late entrant, Inrebic has carved out a niche, particularly for patients who are intolerant or have contraindications to ruxolitinib[5].

Financial Performance

Revenue Growth

Inrebic generated $110 million in product revenues in 2023, a 29% increase from the previous year. This growth indicates a positive market reception despite the drug's late entry into the JAK inhibitor market[2].

Sales Projections

Wall Street estimates for Inrebic's sales are modest compared to other Celgene assets acquired by Bristol-Myers Squibb. Projections range between $300 million to $500 million by 2028, which is lower than the forecasts for other key drugs like ozanimod and luspatercept[4].

Cost and Pricing

The annual treatment cost of Inrebic is substantial, with a 28-day drug acquisition cost of $9,452 per patient and an annual cost of $123,213. This pricing reflects the drug's positioning as a specialized treatment for a rare condition[5].

Competitive Landscape

Existing JAK Inhibitors

Jakafi remains the leading JAK inhibitor, generating $2.594 billion in U.S. net product revenues and $1.72 billion in rest-of-world sales in 2023. Other competitors, such as Ojjaara and Vonjo, also vie for market share, though their revenues are significantly lower than Jakafi's[2].

Emerging Competitors

The JAK inhibitor market is expected to become more crowded with new entrants like Ajax Therapeutics' AJ1-11095, a first-in-class Type II JAK2 inhibitor. These new drugs aim to address the limitations of current JAK inhibitors, such as the lack of disease-modifying activity and the need for better treatment options for patients who no longer benefit from existing drugs[2].

Challenges and Opportunities

Safety Concerns

Inrebic comes with a black box warning for serious and fatal encephalopathy, including Wernicke’s encephalopathy, which was reported in 1.3% of trial patients. This safety concern could impact its adoption and long-term market performance[1].

Market Growth Potential

The market for myelofibrosis treatments is projected to grow at a compound annual growth rate of 5.5% from $749.05 million in 2023 to $1.28 billion in 2033. This growth potential offers opportunities for Inrebic to expand its market share, especially if it can differentiate itself through better efficacy or safety profiles[2].

Strategic Implications for Bristol-Myers Squibb

Acquisition Context

The approval of Inrebic is a significant milestone for Bristol-Myers Squibb's $74 billion acquisition of Celgene. While Inrebic is not the most valuable asset in the deal, its approval validates Bristol-Myers Squibb's strategy of betting on Celgene's experimental pipeline[4].

Pipeline Pressure

Despite the positive news, Bristol-Myers Squibb faces pressure from the loss of Otezla and patent expirations, which could slow top-line growth. The performance of late-stage pipeline drugs, including Inrebic, will be crucial in mitigating these challenges[1].

Key Takeaways

• Approval and Clinical Benefits: Inrebic was approved in 2019 as a treatment for myelofibrosis, showing significant clinical benefits in reducing spleen volume and symptom scores.
• Market Positioning: Inrebic targets patients intolerant or contraindicated to ruxolitinib, carving a niche in the JAK inhibitor market.
• Financial Performance: Inrebic generated $110 million in revenues in 2023, with projected sales between $300 million to $500 million by 2028.
• Competitive Landscape: The JAK inhibitor market is dominated by Jakafi, with emerging competitors aiming to address current treatment limitations.
• Challenges and Opportunities: Safety concerns and market growth potential are key factors influencing Inrebic's long-term market trajectory.

FAQs

What is Inrebic used for?

Inrebic (fedratinib) is used as a treatment for myelofibrosis, a rare bone marrow disorder that disrupts the body’s normal production of blood cells.

Who developed Inrebic?

Inrebic was initially developed by TargeGen, later acquired by Sanofi, and finally revived by Celgene through its acquisition of Impact Biomedicines.

What are the significant clinical benefits of Inrebic?

Inrebic has demonstrated significant clinical benefits, including spleen volume reduction and total symptom score reduction in patients with intermediate-2 or high-risk primary myelofibrosis and secondary myelofibrosis.

What is the annual treatment cost of Inrebic?

The annual treatment cost of Inrebic is approximately $123,213, with a 28-day drug acquisition cost of $9,452 per patient.

How does Inrebic fit into the broader JAK inhibitor market?

Inrebic enters a market dominated by other JAK inhibitors like Jakafi and Ojjaara, targeting patients who are intolerant or have contraindications to ruxolitinib.

Sources

1. FiercePharma: "Once left for dead, Celgene's JAK med Inrebic scores FDA nod eve of takeover"
2. Genetic Engineering & Biotechnology News: "JAK Attack: Ajax Takes Aim at Myelofibrosis"
3. Health Canada: "Summary Basis of Decision for Inrebic"
4. BioPharma Dive: "Celgene wins approval for drug key to Bristol buyout"
5. CADTH: "Reimbursement Recommendation: Fedratinib (Inrebic)"