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Last Updated: February 11, 2025

TRUXIMA Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)Phase 4
Universitaire Ziekenhuizen KU LeuvenPhase 4
Fate TherapeuticsPhase 1

See all TRUXIMA clinical trials

Pharmacology for TRUXIMA
Mechanism of ActionCD20-directed Antibody Interactions
Established Pharmacologic ClassCD20-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 TRUXIMA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: TRUXIMA

Introduction

TRUXIMA, a biosimilar of the biologic drug Rituxan (rituximab), has been making significant waves in the pharmaceutical market. Developed by Celltrion Inc., TRUXIMA has shown promising safety and efficacy, particularly in treating non-Hodgkin's lymphoma, rheumatoid arthritis, and other indications. Here, we delve into the market dynamics and financial trajectory of TRUXIMA.

Market Growth and Projections

The global rituximab biosimilars market, which includes TRUXIMA, is expected to experience rapid growth. By 2026, the market is projected to reach $3.42 billion at a compound annual growth rate (CAGR) of 13.6%[1].

Long-Term Projections

Looking further ahead, the market is anticipated to grow to $4.89 billion by 2028, driven by an aging population, improved healthcare access, and the increasing prevalence of chronic diseases[3].

Market Share and Penetration

TRUXIMA has been gaining substantial market share in both Europe and the United States. As of the third quarter of 2022, it held a market share of 23.6% in Europe and 27.6% in the US[4].

Safety and Efficacy

A post-marketing study involving 677 patients in Korea demonstrated that TRUXIMA has a similar safety profile and high response rate compared to the original drug, Rituxan. This study, published in the journal Expert Opinion on Biological Therapy, evaluated TRUXIMA's use for various indications, including non-Hodgkin's lymphoma and rheumatoid arthritis[4].

Regulatory Approvals

TRUXIMA received regulatory approvals in Korea in 2016, followed by approvals in Europe in 2017 and the US in 2018. These approvals have been crucial in expanding its market reach and acceptance[4].

Financial Performance of Celltrion

The success of TRUXIMA has significantly contributed to Celltrion's financial performance. While specific financial figures for TRUXIMA alone are not detailed, the overall performance of Celltrion and the broader rituximab biosimilars market indicates strong revenue growth.

Revenue Impact

The global market size of rituximab, which includes biosimilars like TRUXIMA, was estimated at $5.9 billion in 2021. This large market size underscores the potential revenue impact of TRUXIMA on Celltrion's financials[4].

Competitive Landscape

The rituximab biosimilars market is competitive, with several players vying for market share. However, TRUXIMA's strong safety and efficacy profile, coupled with its regulatory approvals, has positioned it as a leading biosimilar in this space.

Impact of Global Events

The Russia-Ukraine war and the COVID-19 pandemic have introduced economic uncertainties, including supply chain disruptions and inflation. However, the demand for rituximab biosimilars, driven by the increasing prevalence of non-Hodgkin's lymphoma and other chronic diseases, has remained robust despite these challenges[1].

Strategic Partnerships and R&D Investments

Celltrion has been forging strategic partnerships and investing heavily in research and development to further enhance its biosimilar portfolio. These initiatives are expected to drive innovation and expand the company's market presence[3].

Conclusion

TRUXIMA has established itself as a significant player in the rituximab biosimilars market, driven by its safety, efficacy, and regulatory approvals. The market dynamics, including growing demand for biosimilars and the company's strategic investments, point towards a strong financial trajectory for TRUXIMA.

Key Takeaways

  • Market Growth: The rituximab biosimilars market is expected to reach $3.42 billion by 2026 and $4.89 billion by 2028.
  • Market Share: TRUXIMA holds a substantial market share in Europe and the US.
  • Safety and Efficacy: TRUXIMA has demonstrated a similar safety profile and high response rate compared to Rituxan.
  • Regulatory Approvals: Approved in Korea, Europe, and the US.
  • Financial Impact: Significant revenue potential for Celltrion.
  • Competitive Landscape: Strong competition, but TRUXIMA is a leading biosimilar.
  • Global Events: Economic uncertainties have not dampened demand.

FAQs

Q: What is TRUXIMA and how does it differ from Rituxan?

A: TRUXIMA is a biosimilar of the biologic drug Rituxan (rituximab). It contains the same active ingredient but is developed by a different company, Celltrion Inc.

Q: What are the key indications for TRUXIMA?

A: TRUXIMA is used to treat non-Hodgkin's lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia, Wegener's granulomatosis, and microscopic polyangiitis.

Q: What is the current market share of TRUXIMA in Europe and the US?

A: As of the third quarter of 2022, TRUXIMA held a market share of 23.6% in Europe and 27.6% in the US.

Q: How has the post-marketing study impacted the use of TRUXIMA?

A: The post-marketing study has provided meaningful evidence of TRUXIMA's safety and efficacy, similar to the original drug Rituxan, which has helped in expanding its prescription.

Q: What are the projected market sizes for the rituximab biosimilars market?

A: The market is projected to reach $3.42 billion by 2026 and $4.89 billion by 2028.

Sources

  1. Rituximab Biosimilars Global Market Report 2023 - Biosimilar Development.
  2. Teva Announces Strong Financial Results for the Third Quarter of 2024 - Teva USA.
  3. Rituximab Biosimilars Global Market Size & Forecast to 2028 - Research and Markets.
  4. Celltrion's Truxima shows safety, efficacy in post-marketing study - KED Global.
  5. Fourth Quarter and Full Year 2023 Results - Q4 2023 Earnings Presentation.

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