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Last Updated: January 5, 2025

UPLIZNA Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
AmgenPhase 4

See all UPLIZNA clinical trials

Pharmacology for UPLIZNA
Mechanism of ActionCD19-directed Antibody Interactions
Established Pharmacologic ClassCD19-directed Cytolytic Antibody
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 UPLIZNA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

UPLIZNA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: UPLIZNA

Introduction to UPLIZNA

UPLIZNA, developed by Horizon Therapeutics, is a biologic drug primarily used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG). It has been making significant strides in the pharmaceutical market, particularly in the biologics segment.

Market Scenario for Generalized Myasthenia Gravis

The market for generalized myasthenia gravis is poised for significant growth due to extensive research and increasing healthcare spending globally. This expansion is expected to enable drug manufacturers to penetrate the market more effectively[1][4].

Emerging Therapies and Competition

The landscape for gMG treatments is becoming increasingly competitive with the development of novel therapies. Companies are focusing on innovative approaches to treat and improve the disease condition, which could impact UPLIZNA's market dominance. Other emerging products are expected to provide tough competition, and the launch of late-stage therapies will significantly influence the market[1][4].

Financial Performance of UPLIZNA

Recent Financial Highlights

In the second quarter of 2023, UPLIZNA achieved record net sales of $68 million, representing a 27% sequential increase from the first quarter and a 76% year-over-year increase compared to the second quarter of 2022. The strong performance was driven by robust demand generation, new patient starts, and increased depth among existing prescribers. UPLIZNA has established itself as the fastest-growing biologic in NMOSD by market share[2].

Regional Market Performance

The drug's market performance varies across different regions. Here are some key insights:

  • United States: UPLIZNA net sales in the U.S. were $53 million in the second quarter of 2023, showing a 76% year-over-year increase. This growth is attributed to strong commercial execution and increased patient adherence to maintenance treatment[2].
  • Europe and Japan: Detailed market size analyses for UPLIZNA in the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan are provided in comprehensive reports. These analyses forecast sales data from 2024 to 2032, highlighting the potential for significant market expansion in these regions[1][4].

Mechanism of Action and Clinical Assessment

Mechanism of Action

UPLIZNA works by targeting the CD20 antigen on B cells, which are implicated in the pathogenesis of NMOSD and gMG. By depleting these B cells, UPLIZNA helps in reducing the severity and frequency of attacks associated with these conditions.

Clinical Trials and Regulatory Milestones

The clinical trials for UPLIZNA have shown promising results, with detailed information on trial interventions, conditions, status, and completion dates available. Regulatory milestones and developmental activities are closely monitored, providing a clear picture of the drug's current development scenario[4].

Market Forecast and Analysis

Forecasted Sales Data

The forecasted sales data for UPLIZNA from 2024 to 2032 indicate a positive trajectory. The market size for UPLIZNA in the seven major markets (the U.S., EU4, the U.K., and Japan) is expected to grow, driven by increasing demand and strong commercial execution. This growth will be supported by robust demand generation and new patient starts[1][4].

SWOT Analysis and Competitive Landscape

A detailed SWOT analysis and competitive landscape assessment highlight the strengths, weaknesses, opportunities, and threats for UPLIZNA. The report also provides insights into the competitive landscape, including other marketed and emerging therapies for gMG. This analysis helps in understanding the overall market scenario and the potential challenges and opportunities for UPLIZNA[1].

Impact of Biologic Drugs Market Trends

Global Biologic Drugs Market

The global biologic drugs market, valued at USD 296.2 billion in 2023, is expected to grow to USD 326.12 billion by 2030, with a CAGR of 10.1%. This growth is driven by the increasing demand for effective treatments for chronic conditions such as cancer, autoimmune diseases, and cardiovascular diseases. The therapeutic proteins sub-segment, which includes monoclonal antibodies like UPLIZNA, is projected to generate the maximum revenue[3].

Regional Insights

North America holds a dominant position in the biologic drugs market, driven by a well-developed pharmaceutical industry, access to advanced healthcare facilities, and streamlined regulatory frameworks. These factors facilitate the research, development, and market entry of new biologic therapies, including UPLIZNA[3].

Key Takeaways

  • Growing Market: The market for gMG is expanding due to extensive research and increasing healthcare spending.
  • Strong Financial Performance: UPLIZNA has shown significant financial growth, with record net sales in recent quarters.
  • Regional Growth: The drug is performing well in various regions, including the U.S., EU4, the U.K., and Japan.
  • Competitive Landscape: UPLIZNA faces competition from emerging therapies but remains a dominant player in the NMOSD market.
  • Market Forecast: Forecasted sales data indicate a positive growth trajectory for UPLIZNA from 2024 to 2032.

FAQs

What is UPLIZNA used for?

UPLIZNA is primarily used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG).

How has UPLIZNA performed financially in recent quarters?

UPLIZNA achieved record net sales of $68 million in the second quarter of 2023, representing a 27% sequential increase and a 76% year-over-year increase.

What drives the growth of the biologic drugs market?

The growth of the biologic drugs market is driven by increasing demand for effective treatments for chronic conditions, advanced healthcare facilities, and streamlined regulatory frameworks.

Which regions are key for UPLIZNA's market performance?

The key regions for UPLIZNA's market performance include the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

What is the forecasted market size for UPLIZNA from 2024 to 2032?

The forecasted sales data for UPLIZNA from 2024 to 2032 indicate a positive growth trajectory, driven by robust demand generation and new patient starts.

Sources

  1. Research and Markets: "UPLIZNA Emerging Drug Insight and Market Forecast - 2032"
  2. BioSpace: "Horizon Therapeutics plc Reports Second-Quarter 2023 Financial Results"
  3. Maximize Market Research: "Biological Drugs Market: Global Industry Analysis"
  4. GlobeNewswire: "UPLIZNA for Generalized Myasthenia Gravis (gMG) Emerging Drug Insights, Sales and Market Forecasts 2019-2023-2024-2032"

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