Desirudin - Biologic Drug Details

Summary for desirudin

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 desirudin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for desirudin 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
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271		2006-11-13	DrugPatentWatch analysis and company disclosures
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271		2008-01-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for desirudin 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
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271		2036-12-20	Patent claims search
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271		2035-11-05	Patent claims search
Bausch Health Us, Llc	IPRIVASK	desirudin	For Injection	021271		2035-01-21	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Desirudin

Last updated: July 30, 2025

Introduction

Desirudin, a recombinant human hirudin analog, is a direct thrombin inhibitor primarily indicated for the prevention of deep vein thrombosis (DVT) in patients undergoing major orthopedic surgery, such as total hip or knee replacement. Since its approval, desirudin's market dynamics have been influenced by evolving clinical standards, competitive landscape, and pricing strategies. This report offers a comprehensive analysis of desirudin’s current market environment, growth prospects, and financial trajectory, equipping stakeholders with strategic insights.

Market Overview

Therapeutic Landscape and Indications

Traditionally, desirudin has coexisted within a crowded anticoagulant space that includes low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs), and other injectable agents such as unfractionated heparin. The primary clinical use case has centered on DVT prophylaxis post-orthopedic surgery, a segment forecasted to grow with rising global orthopedic procedures driven by aging populations and increasing osteoarthritis prevalence.

Market Penetration and Adoption

Despite its efficacy, desirudin's market share remains limited compared to entrenched competitors like enoxaparin and rivaroxaban. Regulatory hurdles, physician familiarity with established agents, and reimbursement challenges have historically constrained its uptake. However, recent advances, including improved formulations and repositioning efforts, seek to expand its clinical application beyond orthopedic procedures into other thrombotic risk scenarios.

Market Drivers and Restraints

Drivers

1. Growing Orthopedic Surgery Volume:
   The global increase in osteoarthritis cases and aging demographics contributes directly to the expansion of inpatient orthopedic procedures, multiplying potential demand.

2. Efficacy and Safety Profile:
   Desirudin's high specificity for thrombin and favorable safety profile—particularly its low risk of heparin-induced thrombocytopenia (HIT)—positions it favorably in patient subsets requiring high safety standards.

3. Regulatory Approvals and Orphan Status:
   Approved by the FDA since the late 1990s for DVT prevention, desirudin benefits from a relatively stable regulatory environment, though newer approvals or extensions could trigger market expansion.

Restraints

1. Pricing and Reimbursement Challenges:
   Higher costs compared to generic LMWHs impact its competitive positioning, especially within cost-sensitive healthcare systems.

2. Limited Indications:
   Currently approved mainly for DVT prophylaxis in orthopedic surgery, constraining broader market potential.

3. Competitive Dynamics:
   The advent of DOACs offers oral, convenient alternatives with comparable efficacy, diminishing desirudin's relative attractiveness.

Competitive Landscape

The dominant players in the anticoagulant market include:

• Rivaroxaban (Xarelto): Orally administered, broad indications.
• Apixaban (Eliquis): Similar profile with favorable safety.
• Dabigatran (Pradaxa): Direct thrombin inhibitor, oral formulation.
• LMWHs (e.g., enoxaparin): Established intraoperative and postoperative use.

Desirudin's unique intravenous administration and specific safety profile differentiate it but have not decisively translated into market dominance.

Financial Trajectory Analysis

Revenue Trends

Historical revenue data indicates that desirudin has maintained modest sales volumes, primarily in North America and select European markets. A 2019 market report estimates annual sales ranging between $50 million to $80 million, with a slight upward trend correlated with orthopedic procedure volumes.

Factors Influencing Revenue Growth

• Market Penetration Rate: Slow growth due to physician inertia and reimbursement policies.
• Pricing Strategies: Premium pricing — necessary to offset clinical benefits — limits volume expansion.
• Pipeline Developments: Efforts to develop biosimilars or innovator formulations could influence future revenues.

Future Projections

Forecast models project a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, contingent on:

• Expansion into new indications: Thrombosis prevention in cancer-associated thrombosis or cardiovascular interventions.
• Market penetration: Greater adoption in non-orthopedic surgical procedures.
• Regulatory approvals: Indications for prophylaxis in atrial fibrillation or other high-risk populations.

However, these projections could be dampened by increased competition from DOACs, which benefit from oral delivery and established clinical convenience, thereby reducing desirudin's growth prospects.

Regulatory and Market Accessibility Considerations

Numerous regions continue to evaluate desirudin through post-marketing studies and clinical trials aimed at broadening its indications. Regulatory agencies’ perspectives on biosimilar entry and pricing frameworks will significantly influence desirudin’s financial trajectory.

Opportunities and Challenges

Opportunities

• Application in Non-Orthopedic Surgeries: Expanding use cases into various surgical and medical settings.
• Combination Therapies: Pairing desirudin with other anticoagulants for personalized therapy.
• Biosimilar Development: Potential for cost reductions and broader access.

Challenges

• Price Competition: Cost pressures from generics and biosimilars.
• Clinical Preference Shift: Physicians favoring oral agents due to ease of administration.
• Market Saturation: Limited incremental demand in existing approved indications.

Conclusion

Desirudin’s market remains specialized but stable, with modest growth driven by demographic trends and clinical efficacy. Competitive pressures, especially from oral anticoagulants, pose significant obstacles. Strategic expansion into new indications and markets, alongside innovation in formulations and pricing, will determine its long-term financial trajectory.

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Key Takeaways

• The demand for desirudin is closely linked to orthopedic surgery volumes, with slow but steady growth projections.
• Its unique safety profile offers niche advantages but struggles against more convenient oral alternatives.
• Market expansion relies on regulatory approval for broader indications and strategic positioning.
• Revenue growth will be constrained by high costs and limited indications but can benefit from opportunities in non-orthopedic thrombotic settings.
• Competition from DOACs remains a significant factor influencing desirudin’s market share and profitability.

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FAQs

1. What are the primary clinical advantages of desirudin over other anticoagulants?
Desirudin offers high specificity for thrombin with a low risk of HIT, providing a safety advantage in high-risk patient populations, especially within surgical settings.

2. How does desirudin’s market share compare to oral anticoagulants like rivaroxaban?
Desirudin’s market share is significantly smaller due to the convenience and established efficacy of oral agents, though it retains specific niche applications.

3. Are there ongoing efforts to expand desirudin’s approved indications?
Yes, clinical trials are exploring its utility in other thrombotic conditions, which could facilitate regulatory approvals and market expansion.

4. What factors could positively influence desirudin’s revenue growth?
Market expansion into non-orthopedic surgeries, development of biosimilars, and favorable regulatory decisions are potential growth catalysts.

5. How might biosimulant competition impact desirudin’s financial trajectory?
Biosimilars could lower costs, increase accessibility, and stimulate demand, but also challenge current pricing and market share dominance.

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References

[1] Market Research Future. "Biologic Drugs Market Analysis." 2022.
[2] GlobalData Healthcare. "Anticoagulants Market Forecast." 2022.
[3] U.S. Food and Drug Administration. "Desirudin (Ipravask) Label Information." 2018.
[4] EvaluatePharma. "Biologics Sales and Market Data." 2022.
[5] American Society of Hematology. "Thrombosis and Hemostasis Report." 2021.