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Last Updated: February 12, 2025

UNITUXIN Drug Profile


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Summary for Tradename: UNITUXIN
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for UNITUXIN
Recent Clinical Trials for UNITUXIN

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Prof. Franca FagioliPhase 2
Children's Oncology GroupPhase 2
Nationwide Children's HospitalPhase 1

See all UNITUXIN clinical trials

Pharmacology for UNITUXIN
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for UNITUXIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for UNITUXIN Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for UNITUXIN Derived from Patent Text Search

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for the Biologic Drug: UNITUXIN

Introduction

UNITUXIN, also known as dinutuximab, is a monoclonal antibody approved for the treatment of pediatric patients with high-risk neuroblastoma. This drug has been a significant player in the neuroblastoma drugs market, driven by several key factors.

Approval and Regulatory Milestones

UNITUXIN was approved by the U.S. Food and Drug Administration (FDA) on March 10, 2015, as part of first-line therapy for pediatric patients with high-risk neuroblastoma. This approval was a result of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and United Therapeutics Corporation (UTC)[1].

Market Drivers

The global neuroblastoma drugs market, which includes UNITUXIN, is driven by several factors:

Growing Demand for Anti-GD2 Antibodies

The market is significantly driven by the growing demand for anti-GD2 antibodies. Dinutuximab, being the first identified drug acting as an anti-GD2-specific monoclonal antibody, has been pivotal in this segment. These antibodies provide site-specific action, eliminating tumor cells that express GD2 without posing cytotoxic effects, thus improving the quality of life for neuroblastoma patients[4].

Increasing R&D for Neuroblastoma Treatments

Research and development efforts for treating relapsed or refractory neuroblastoma are also boosting the market. The continuous innovation in targeted therapies and the integration of personalized medicine approaches are expanding the therapeutic potential of biologics like UNITUXIN[3].

Regulatory Support

The FDA’s issuance of a rare pediatric disease priority review voucher to UTC further facilitated the commercialization of UNITUXIN. This voucher system incentivizes the development of treatments for rare pediatric diseases[1].

Financial Performance of United Therapeutics

The financial trajectory of UNITUXIN is closely tied to the performance of United Therapeutics Corporation.

Revenue Growth

In the second quarter of 2024, United Therapeutics reported strong financial results, with total revenues growing 20% year-over-year to $714.9 million. While the specific revenue figures for UNITUXIN are not detailed in the latest reports, the overall growth of the company's product portfolio, including Tyvaso and Remodulin, indicates a robust financial performance[5].

Net Income and EPS

The company's net income increased by 7% to $278.1 million, and diluted EPS rose by 12% to $5.85. These financial metrics reflect the company's overall health and its ability to invest in research and development, which is crucial for the continued success of drugs like UNITUXIN[5].

Research and Development Expenses

United Therapeutics has significantly increased its research and development expenses, which rose by 57% to $139.6 million in Q2 2024. This investment is critical for the development of new treatments and the enhancement of existing products, including UNITUXIN[5].

Market Outlook

The biologics market, which includes drugs like UNITUXIN, is expected to grow substantially.

Biologics Market Size

The biologics market size reached $349.6 billion in 2023 and is projected to grow to $699.5 billion by 2032, exhibiting a CAGR of 7.8% during the forecast period. This growth is driven by the rising prevalence of chronic diseases, technological advancements, and the increasing adoption of biosimilars[3].

Neuroblastoma Drugs Market

The global neuroblastoma drugs market is expected to grow, driven by the demand for anti-GD2 antibodies and other targeted therapies. The market is anticipated to grow by $190.82 million during the forecast period, progressing at a CAGR of over 4%[4].

Competitive Landscape

UNITUXIN operates in a competitive market that includes other pharmaceutical companies such as Bristol Myers Squibb and Johnson & Johnson. However, its unique mechanism of action and regulatory approvals give it a significant edge in the treatment of pediatric neuroblastoma[4].

Key Takeaways

  • Regulatory Approvals: UNITUXIN received FDA approval in 2015 and European Commission authorization in 2015, marking significant milestones.
  • Market Drivers: Growing demand for anti-GD2 antibodies and increasing R&D efforts drive the market.
  • Financial Performance: United Therapeutics' strong financial results, including revenue and net income growth, support the drug's commercial success.
  • Market Outlook: The biologics and neuroblastoma drugs markets are expected to grow significantly, driven by technological advancements and increasing demand.

FAQs

What is UNITUXIN used for?

UNITUXIN (dinutuximab) is used in combination with other therapies for the treatment of pediatric patients with high-risk neuroblastoma.

Who developed and markets UNITUXIN?

UNITUXIN was developed through a CRADA between the NCI and United Therapeutics Corporation, which also markets the drug under the brand name Unituxin[1].

What is the significance of the FDA’s rare pediatric disease priority review voucher?

The FDA’s issuance of a rare pediatric disease priority review voucher to UTC incentivized the development and commercialization of treatments for rare pediatric diseases, including UNITUXIN[1].

How is the biologics market expected to grow?

The biologics market is expected to grow from $349.6 billion in 2023 to $699.5 billion by 2032, with a CAGR of 7.8% during the forecast period[3].

What are the key drivers of the neuroblastoma drugs market?

The key drivers include the growing demand for anti-GD2 antibodies, increasing R&D for relapsed or refractory neuroblastoma, and favorable regulatory environments[4].

Sources

  1. NCI: Dinutuximab (Unituxin™) - An NIH Success Story - NCI
  2. Business Wire: United Therapeutics Corporation Reports Third Quarter 2022 Financial Results
  3. Biospace: Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems
  4. Biospace: Global Neuroblastoma Drugs Market 2019-2023 | Technavio
  5. Stocktitan: United Therapeutics Corporation Reports Second Quarter 2024 Financial Results

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