Glucarpidase - Biologic Drug Details

Summary for glucarpidase

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

Recent Clinical Trials for glucarpidase

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 1
BTG International Inc.	Phase 1
BioClever 2005 S.L.	Phase 2

See all glucarpidase clinical trials

Pharmacology for glucarpidase

Established Pharmacologic Class	Carboxypeptidase
Chemical Structure	Carboxypeptidases

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 glucarpidase Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for glucarpidase 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
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2023-01-09	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2024-09-14	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2029-09-23	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2031-12-19	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2034-06-02	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2033-04-08	DrugPatentWatch analysis and company disclosures
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2035-09-08	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for glucarpidase 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
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2037-03-01	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2038-09-17	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2038-05-17	Patent claims search
Btg International Inc.	VORAXAZE	glucarpidase	For Injection	125327		2038-10-25	Patent claims search

International Patents for glucarpidase

Country	Patent Number	Estimated Expiration
Chile	2013001776
Chile	2017000772
Canada	2819269
Brazil	112013014527
Taiwan	201536807
China	103347897
World Intellectual Property Organization (WIPO)	03070268

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for the Biologic Drug: Glucarpidase

Introduction
Glucarpidase, marketed as Voraxase or Carimest, is a recombinant enzyme biologic used primarily to counteract high-dose methotrexate (HDMTX) toxicity. It acts by rapidly hydrolyzing methotrexate into inactive constituents, enabling swift clearance in cases of renal impairment or delayed elimination. As a niche but critical therapeutic agent, glucarpidase's market evolution hinges on multiple clinical, regulatory, and economic factors influencing its adoption and growth trajectory.

Clinical Context and Therapeutic Landscape
Methotrexate, a cornerstone chemotherapeutic, is utilized across oncologic and autoimmune indications. While high-dose methotrexate enhances treatment efficacy, it predisposes patients to severe toxicities, including nephrotoxicity and hematologic complications. Glucarpidase serves as a rescue agent for patients with delayed methotrexate clearance, particularly in cases of renal impairment[^1].

The drug's effectiveness has established it as a vital tool in cancer centers worldwide. Nonetheless, its clinical adoption depends on healthcare provider awareness, institutional protocols, and the availability of alternative detoxification measures such as hydration and leucovorin rescue. Advances in supportive care and the development of targeted therapeutic protocols influence the drug’s utilization rate.

Market Players and Regulatory Milestones
Currently, Endo Pharmaceuticals holds the FDA approval for Voraxaze (glucarpidase) since 2012[^2]. The patent estate and regulatory exclusivities shape the competitive landscape, while biosimilar development remains limited due to the biologic’s complexity and the relatively specialized indication.

Market expansion is further constrained by the drug’s high cost, limited indications, and logistical challenges related to its administration. However, in regions with advanced healthcare infrastructure, glucarpidase remains a standard rescue option, underpinning steady demand.

Market Dynamics
Several factors influence the dynamics of the glucarpidase market:

• clinical demand: The need for rapid methotrexate clearance in toxicity scenarios sustains a stable demand, especially in oncology centers with high HDMTX utilization. The increasing adoption of high-dose methotrexate protocols in lymphoma, osteosarcoma, and CNS tumors sustains the core need for glucarpidase[^3].

• Regulatory environment: Approval of glucarpidase in countries outside the U.S. and Europe, including Japan and parts of Asia, broadens market accessibility. Regulatory hurdles related to manufacturing standards and post-market data requirements influence market expansion.

• Pricing and reimbursement: High treatment costs (approximately $15,000 - $20,000 per dose) restrict widespread use in cost-sensitive markets. Reimbursement policies significantly impact adoption, with favorable coverage propelling sales.

• Emerging therapies and alternatives: Growth in the use of alternative detoxification agents or novel chemotherapeutic strategies could impact demand. However, current alternatives lack the rapidity and specificity of glucarpidase, maintaining its niche.

• Manufacturing and supply chain: The production of recombinant biologics requires specialized facilities and quality control. Any disruptions in manufacturing capacity can affect market supply.

Financial Trajectory and Market Forecast
Analysts project that the global glucarpidase market will witness moderate growth over the next five years, driven predominantly by medical need, geographic expansion, and increasing high-dose methotrexate usage[^4].

• Market Size: The global biologics segment related to methotrexate rescue is estimated to reach approximately $300 million annually by 2028, with a compound annual growth rate (CAGR) of around 7-10%.

• Geographical Trends: North America commands the largest market share, owing to high HDMTX use, advanced healthcare infrastructure, and reimbursement policies. Europe follows, with steady growth. The Asian markets show potential due to expanding oncology care and increased healthcare spending, though current penetration remains lower.

• Pricing Trends: While the drug's high cost remains a challenge, price reductions may become feasible through generic or biosimilar development, especially in emerging markets.

• Pipeline and Innovation: Currently, no significant pipeline competitors are positioned to replace glucarpidase's unique rapid detoxification mechanism. Advances in predictive biomarkers and personalized therapy are unlikely to diminish immediate need but may influence long-term use.

Market Challenges and Opportunities

• Challenges: High drug costs, limited indications, and the need for cold chain logistics constrain broader utilization. Regulatory and patent hurdles may delay the entry of biosimilars or alternative products.

• Opportunities: Expanding indications, developing cost-efficient biosimilars, and enhancing global access, particularly in developing regions, promise future growth avenues. Additionally, integrating glucarpidase into broader supportive care programs can enhance utilization.

Concluding Remarks on Market and Financial Outlook
The outlook for glucarpidase remains cautiously optimistic. Its role as an essential rescue agent in high-dose methotrexate therapy sustains stable demand within its niche. Nonetheless, market growth hinges on healthcare system advancements, policy reforms, and innovations that improve accessibility and reduce costs. The gradual penetration of emerging markets and potential biosimilar entrants could further influence the drug’s financial trajectory, making strategic positioning vital for stakeholders.

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Key Takeaways

• Glucarpidase remains a critical biologic in managing methotrexate toxicity, with demand stable in high-dose chemotherapy settings.
• The global market is forecasted to grow at a CAGR of approximately 7-10%, driven by increased drug utilization and geographic expansion.
• High drug costs and reimbursement challenges limit broader adoption, especially in low-resource settings.
• Emergence of biosimilars and pipeline innovations could influence future pricing and market competition.
• Strategic efforts to expand indications and improve supply chain efficiency are essential for sustained growth.

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FAQs

1. What factors primarily drive the demand for glucarpidase globally?
Demand is driven by the prevalence of high-dose methotrexate use in oncology, particularly for lymphomas and osteosarcomas, and the need for rapid detoxification in cases of toxicity or impaired renal function.

2. How does the regulatory landscape influence the market for glucarpidase?
Regulatory approvals in various countries facilitate market entry and expansion. Stringent quality and safety standards may pose hurdles, while patent protections can delay biosimilar competition, impacting pricing and availability.

3. What are the main challenges facing glucarpidase commercialization?
High manufacturing costs, limited indications, high pricing, reimbursement barriers, and logistical complexities comprise significant challenges that could restrict market penetration.

4. Are there emerging competitors to glucarpidase?
Currently, no direct biosimilar competitors exist; its unique enzymatic mechanism offers limited alternative options, sustaining its niche role. Future pipeline candidates are limited, maintaining its market exclusivity in the near term.

5. How might biosimilars impact the future of the glucarpidase market?
Biosimilars could reduce costs and improve access, especially in emerging markets. Their development depends on regulatory pathways and patent landscapes, and their entry could intensify market competition.

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Sources:
[1] National Center for Biotechnology Information (NCBI). "Glucarpidase: A Review." (2021)
[2] FDA. Voraxaze (glucarpidase) Prescribing Information. 2012.
[3] MarketWatch. "Biologics in Oncology and the Role of Glucarpidase." (2022)
[4] Grand View Research. "Global Market Insights on Methotrexate Rescue Agents." (2023)