You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

~ Buy the INREBIC (fedratinib hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

INREBIC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 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

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for INREBIC?
  • What are the global sales for INREBIC?
  • What is Average Wholesale Price for INREBIC?
Drug patent expirations by year for INREBIC
Drug Prices for INREBIC

See drug prices for INREBIC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INREBIC
Generic Entry Date for INREBIC*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Joseph JurcicPhase 1
Bristol-Myers SquibbPhase 1
H. Lee Moffitt Cancer Center and Research InstitutePhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INREBIC is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 10363329
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷  Subscribe

Patent: 11323108
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2013011184
Patent: composições e métodos para tratamento de mielofibrose
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 16710
Patent: COMPOSITIONS ET METHODES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Patent: 16957
Patent: COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 13001252
Patent: Capsula para administracion oral que comprende n-terc-butil-3-[(5-metil-2-{[4-(2-pirrolidin-1-iletoxi)fenil]amino}pirimidin-4-il)amino]bencenosulfonamida, una celulosa microcristalina y estearil fumarato de sodio; forma de dosificacion unitaria; metodo para tratar mielofibrosis; metodo de preparacion; y articulo de preparacion.
Estimated Expiration: ⤷  Subscribe

China

Patent: 3282036
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷  Subscribe

Patent: 8125923
Patent: 用于治疗骨髓纤维化的组合物和方法 (Compositions and methods for treating myelofibrosis)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 01724
Patent: Composiciones y métodos para el tratamiento de la mielofibrosis
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0221269
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 35282
Estimated Expiration: ⤷  Subscribe

Dominican Republic

Patent: 013000097
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 13012658
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 35282
Patent: COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Patent: 59216
Patent: COMPOSITIONS DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 60254
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6101
Patent: פורמולציות קפסולה של n-טרט-בוטיל-3-[(5 -מתיל-2-{[4-(2 -פירולידין-1-אילאתוקסי(פניל[אמינו{פירימידין-4-איל)אמינו]בנזינסולפונאמיד ושימוש בהן להכנת תרופות לטיפול במיאלופיברוזיס (Capsule formulations of n-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide and use thereof in the preparation of medicaments for treating myelofibrosis)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 33211
Estimated Expiration: ⤷  Subscribe

Patent: 13541595
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 35282
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 1164
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 0246
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS. (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS.)
Estimated Expiration: ⤷  Subscribe

Patent: 13005020
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS. (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS.)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 723
Patent: COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE LA MYÉLOFIBROSE
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 1363
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷  Subscribe

Nicaragua

Patent: 1300038
Patent: COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 140389
Patent: COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 35282
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 35282
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 16262
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА (COMPOSITIONS AND METHODS FOR MYELOFIBROSIS TREATMENT)
Estimated Expiration: ⤷  Subscribe

Patent: 13126121
Patent: КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ МИЕЛОФИБРОЗА
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 996
Patent: KOMPOZICIJE ZA LEČENJE MIJELOFIBROZE (COMPOSITIONS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 0134
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 35282
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1303423
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1940979
Estimated Expiration: ⤷  Subscribe

Patent: 2131241
Estimated Expiration: ⤷  Subscribe

Patent: 130137647
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Patent: 180122029
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Patent: 200083676
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Patent: 240029118
Patent: 골수 섬유증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 30650
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 31389
Estimated Expiration: ⤷  Subscribe

Patent: 1306882
Patent: Compositions and methods for treating myelofibrosis
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 13000195
Patent: COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 4076
Patent: КОМПОЗИЦІЯ І СПОСІБ ЛІКУВАННЯ МІЄЛОФІБРОЗУ
Estimated Expiration: ⤷  Subscribe

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 ⤷  Subscribe
South Korea 20080066066 BI-ARYL META-PYRIMIDINE INHIBITORS OF KINASES ⤷  Subscribe
Canada 2816957 COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS) ⤷  Subscribe
New Zealand 567851 Bi-aryl meta-pyrimidine inhibitors of kinases ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INREBIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1951684 14/2021 Austria ⤷  Subscribe 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 ⤷  Subscribe 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 ⤷  Subscribe 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 ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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)"

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.