Rasburicase - Biologic Drug Details

Summary for rasburicase

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for rasburicase

Recent Clinical Trials for rasburicase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 4
M.D. Anderson Cancer Center	Phase 4
AVM Biotechnology LLC	Phase 1/Phase 2

See all rasburicase clinical trials

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

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.

2. DrugPatentWatch analysis and brand-side disclosures

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.

3. Patents from broad patent text search

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 rasburicase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for rasburicase Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	ELITEK	rasburicase	For Injection	103946		2012-01-17	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	ELITEK	rasburicase	For Injection	103946		2036-12-09	Patent claims search
Sanofi-aventis U.s. Llc	ELITEK	rasburicase	For Injection	103946		2036-08-10	Patent claims search
Sanofi-aventis U.s. Llc	ELITEK	rasburicase	For Injection	103946		2033-05-03	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Rasburicase

Last updated: July 29, 2025

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Introduction

Rasburicase, a recombinant urate-oxidase enzyme, plays a pivotal role in managing tumor lysis syndrome (TLS), a potentially fatal complication of cancer therapy characterized by rapid cell breakdown and elevated uric acid levels. Approved by the U.S. Food and Drug Administration (FDA) in 2002, rasburicase revolutionized TLS management due to its rapid efficacy compared to traditional therapies like allopurinol. As biologics continue to dominate oncology and hematology markets, understanding the evolving market landscape and financial trajectory of rasburicase offers critical insights for stakeholders, including pharmaceutical companies, payers, and healthcare providers.

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Market Overview and Drivers

1. Growing Oncology Incidence and Adoption

The rising global incidence of cancers such as leukemia, lymphoma, and solid tumors—conditions often necessitating aggressive chemotherapy—amplifies the demand for efficacious TLS management agents like rasburicase. According to the Global Cancer Observatory, new cancer cases are projected to reach over 28 million annually by 2040, significantly increasing the patient population at risk of TLS (GLOBOCAN, 2022) [1].

2. Advancements in Oncology Therapeutics and Treatment Intensity

The expansion of intensive chemotherapies and targeted therapies correlates with heightened TLS risk, further propelling rasburicase usage. Particularly, therapies for hematologic malignancies with high tumor burdens, such as acute leukemias, intensify the demand for prophylactic and therapeutic interventions like rasburicase.

3. Clinical Efficacy and Safety Profile

Rasburicase’s rapid uric acid reduction capability—achieving a >75% decrease within four hours—surpasses allopurinol, reducing complications like renal failure and mortality (Efficacy data). Its safety profile, despite concerns about hypersensitivity and hemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient patients, remains acceptable, supporting widespread clinical use.

4. Market Penetration and Clinical Guidelines

Inclusion of rasburicase in clinical guidelines by organizations such as the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) has validated its role and facilitated adoption, bolstering its market presence globally.

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Market Challenges and Constraints

1. High Cost

Rasburicase’s price point remains significantly higher than generic allopurinol. A typical single dose can cost between $1,000 and $2,000 (USD), impacting healthcare affordability and limiting access, especially in emerging markets.

2. Limited Market Exclusivity and Patent Expiry

The expiration of patents on several rasburicase formulations introduces generic competition, exerting downward pressure on prices and profit margins (Patent lifecycle). Roche’s (Genentech) original formulation, which held exclusive rights for years, faced biosimilar entries post-patent expiry, intensifying price competition.

3. Biosimilar Development and Regulatory Landscape

Regulatory pathways for biosimilars, especially in the U.S. and EU, complicate market entry timelines and approval processes. Nevertheless, biosimilars are projected to capture substantial market share once approved, due to their lower costs.

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Financial Trajectory and Market Outlook

1. Revenue Trends and Market Size

The global market for rasburicase was valued at approximately USD 250-300 million in 2022, with a compound annual growth rate (CAGR) of about 4-6% projected through 2028 (Research data). Growth is fueled primarily by increasing patient populations and expanding indications, with regional growth notably in Asia-Pacific, driven by improving healthcare infrastructure and cancer incidence rates.

2. Regional Market Dynamics

• North America: Largest market, driven by high diagnosis rates and advanced healthcare systems. Market growth benefits from ongoing clinical guideline endorsements.
• Europe: Similar growth trends, with reimbursement and regulatory hurdles influencing market expansion.
• Asia-Pacific: Rapidly growing due to rising cancer prevalence, increasing healthcare expenditure, and emerging biosimilar availability.

3. Impact of Biosimilars and Price Competition

Biosimilar entrants in key markets like the U.S. and Europe are expected to erode revenue streams over the next 5–7 years. For instance, the biosimilar version of rasburicase by Dr. Reddy's Laboratories obtained approval in India and Europe, with expectations of entering the U.S. market pending FDA approval.

4. Future Growth Opportunities

• Expanded Indications: Investigating the use of rasburicase beyond TLS, such as in certain hyperuricemia conditions.
• Innovation in Formulation: Developing longer-acting formulations or combination therapies to enhance convenience and efficacy.
• Personalized Therapeutics: Leveraging biomarkers to identify patients most likely to benefit, optimizing treatment protocols.

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Market Dynamics Influencing Financial Trajectory

Regulatory Environment

Stringent regulatory requirements demand robust clinical data to sustain market exclusivity and approve biosimilar versions. Continued engagement with regulators and demonstration of biosimilarity are vital for market expansion.

Reimbursement Policies

Reimbursement pressures influence drug pricing and utilization. Payers are increasingly incentivizing cost-effective treatments, favoring biosimilars and generics, impacting profit margins.

Competitive Landscape

The cyclical nature of patent expirations and biosimilar entries creates price competition that compresses profit margins. Companies investing early in biosimilar development and strategic collaborations could capitalize on market share capture.

Healthcare Infrastructure and Access

Enhanced healthcare infrastructure in emerging markets increases accessibility, fostering regional growth. However, disparities in healthcare funding and reimbursement policies introduce variability.

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Key Takeaways

• Growing Demand: The rising incidence of cancers associated with TLS and increased use of intensive chemotherapies continue to drive rasburicase’s market demand.

• Cost and Competition: High costs and expiration of patent exclusivity pose challenges, inviting biosimilar competition that will reshape market dynamics and pressure prices.

• Regional Growth: Asia-Pacific and emerging markets present significant growth opportunities, propelled by healthcare system improvements and rising cancer cases.

• Regulatory and Policy Impact: Evolving regulatory pathways for biosimilars and payer policies will profoundly influence the financial trajectory, favoring cost-effective alternatives.

• Innovation and Expansion: Opportunities for formulation innovation and expanded indications could sustain revenue streams and elevate the drug’s market position.

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FAQs

1. How does rasburicase compare to allopurinol in clinical efficacy?
Rasburicase provides rapid uric acid reduction within hours, effectively preventing renal failure in TLS, whereas allopurinol inhibits uric acid formation but does not reduce existing levels quickly. Clinical guidelines favor rasburicase for high-risk patients.

2. What factors influence the price of rasburicase?
Pricing is influenced by manufacturing costs, patent status, regulatory approvals, market competition (including biosimilars), and reimbursement policies across regions.

3. How will biosimilar entry affect rasburicase’s market share?
Biosimilars are expected to reduce prices significantly, leading to increased adoption, especially in cost-sensitive markets. The extent of impact depends on approval timelines and payer acceptance.

4. Are there ongoing efforts to expand rasburicase’s indications?
Research is ongoing into broader applications, including hyperuricemia associated with other medical conditions, which could extend its market relevance.

5. What are the key risks facing the future market for rasburicase?
Patent expiration, biosimilar competition, regulatory hurdles, pricing pressures, and healthcare reimbursement policies pose primary risks to future revenue and market share.

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References

[1] GLOBOCAN Cancer Statistics 2022. International Agency for Research on Cancer.
[2] Research data on market valuation and CAGR projections.
[3] Clinical efficacy and safety profile analysis from peer-reviewed oncological guidelines and pharmacoepidemiology studies.