Antithrombin (recombinant) - Biologic Drug Details

Summary for antithrombin (recombinant)

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 antithrombin (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antithrombin (recombinant) 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
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2015-02-21	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2023-05-16	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2025-11-14	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2030-02-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antithrombin (recombinant) 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

International Patents for antithrombin (recombinant)

Country	Patent Number	Estimated Expiration
Canada	2197675
World Intellectual Property Organization (WIPO)	2007048122
Slovenia	1945665
Denmark	1945665
Argentina	058129
European Patent Office	0773992

Market Dynamics and Financial Trajectory for the Biologic Drug: Antithrombin (Recombinant)

Last updated: September 14, 2025

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Introduction

Antithrombin (recombinant), a biologic therapeutic designed to regulate coagulation by enhancing antithrombin activity, is rapidly evolving within the thrombosis management landscape. Its development trajectory, market dynamics, and financial prospects are shaped by regulatory advances, clinical needs, competitive landscape, and technological innovations. Analyzing these factors offers critical insights for investors, pharmaceutical companies, and healthcare providers.

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Understanding Antithrombin (Recombinant): Therapeutic Profile and Clinical Significance

Antithrombin (AT) is a naturally occurring glycoprotein that inhibits thrombin and other coagulation factors. Congenital or acquired deficiencies elevate thrombosis risks, prompting the use of supplemental antithrombin in high-risk scenarios, such as surgery or disseminated intravascular coagulation (DIC). Traditionally, plasma-derived antithrombin has been employed, but recombinant variants offer benefits—including enhanced purity, consistent supply, and reduced risk of pathogen transmission.

Recombinant antithrombin (rAT) candidates are designed to mimic natural activity with improved pharmacokinetics and stability. These biologics are particularly relevant in cases where plasma-derived products face supply constraints, safety concerns, or regulatory limitations.

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Market Dynamics

1. Current Market Landscape and Key Players

The global antithrombin market is currently niche but expanding, propelled by increased awareness of thrombosis risks and advances in biologic manufacturing. Major pharmaceutical entities such as CSL Behring, Kedrion Biopharma, and others dominate with plasma-derived products, yet recombinant versions are emerging.

Innovator companies like GlaxoSmithKline (GSK) and Novartis have invested in recombinant antithrombin research, leveraging biotechnological advancements to develop safer, more effective therapies. Notably, GSK's recombinant AT project entered clinical trials, emphasizing the pharma sector's interest.

2. Regulatory Environment and Approvals

Regulatory pathways influence market entry and growth. The approval of recombinant antithrombin hinges on demonstrating comparable efficacy to plasma-derived products and a superior safety profile. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) impose strict standards, often requiring robust clinical trial data.

Recent regulatory developments favor biologics, providing accelerated pathways for therapies addressing unmet needs. As of 2023, recombinant antithrombin is in various phases of clinical trials, with some European regulators showing openness to fast-track approvals given compelling data.

3. Clinical Pipeline and Adoption Drivers

Ongoing clinical trials evaluate the efficacy and safety of recombinant AT in thrombotic conditions, including hereditary antithrombin deficiency, perioperative management, and sepsis-induced DIC. Positive results could catalyze market adoption. The growing pediatric and geriatric populations, prone to coagulopathies, further expand the potential patient base.

Healthcare providers prioritize therapies offering reduced pathogen transmission risk, consistent dosing, and logistical convenience, all of which recombinant antithrombin aims to provide. These factors favor market penetration once regulatory approvals are secured.

4. Competitive and Technological Challenges

Despite promising advantages, recombinant antithrombin faces challenges:

• Manufacturing Complexity: Producing recombinant biologics involves sophisticated bioprocessing, high costs, and stringent quality controls.
• Pricing and Reimbursement: Biologics are typically priced higher than plasma-derived counterparts, affecting adoption in cost-sensitive markets.
• Market Entrenchment: Plasma-derived products have established clinical use and reimbursement pathways, creating slow adoption curves for recombinant variants.

Overcoming these requires compelling clinical evidence, cost-effective manufacturing, and strategic market entry.

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Financial Trajectory

1. Investment Trends and Funding Landscape

Investment in biologics targeting coagulation disorders, including recombinant antithrombin, has seen a steady uptick. Venture capital and industry partnerships are fueling clinical development pipelines, with some companies securing grants for innovative bioprocessing techniques.

In 2022-2023, several biotech firms reported increased capital infusion geared toward rare disease solutions, positioning recombinant antithrombin products for accelerated development and commercial readiness.

2. Revenue Projections and Market Potential

Market estimates project a modest initial valuation, reflecting the therapy's niche status. However, with successful clinical trials and regulatory approvals, projections vary:

• Short-term (next 3-5 years): Limited revenue generation due to ongoing trials, manufacturing scaling, and regulatory processes.

• Medium-term (5-10 years): Potential to capture a significant niche, especially in perioperative and critical care settings, with annual revenues reaching hundreds of millions USD.

Some industry analysts estimate the global biologics coagulation market could reach $3 billion by 2030, with recombinant antithrombin accounting for a fraction within specialty coagulation therapeutics.

3. Cost-Benefit and Market Access Dynamics

Payor acceptance hinges on demonstrating cost-effectiveness—particularly reduced adverse events and improved patient outcomes compared to traditional plasma-derived products. Reimbursement strategies tailored to high-value biologics are critical to financial success.

The development of biosimilars or lower-cost manufacturing techniques could affect revenue streams by enabling broader access, impacting pricing and profit margins.

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Market Opportunities and Strategic Considerations

• Strategic Partnerships: Collaborations with biotech firms and academic institutions can accelerate development timelines.
• Geographic Expansion: Emerging markets with rising thrombotic disease burdens and less aggressive regulatory landscapes offer growth avenues.
• Pipeline Diversification: Developing combination therapies with other anticoagulants could expand indications and market size.

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Regulatory and Ethical Considerations

Ensuring robust safety profiles, particularly regarding immunogenicity and long-term effects, is fundamental. Equally, intellectual property rights on recombinant technologies influence market exclusivity and revenue potential.

Ethical manufacturing practices and transparency in clinical data reporting will facilitate regulatory approval and public acceptance.

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Key Takeaways

• Recombinant antithrombin offers a promising alternative to plasma-derived products, with advantages in safety, supply consistency, and manufacturing quality.
• Market growth depends heavily on successful clinical trials, regulatory approvals, and reimbursement strategies, with a likely modest market share initially expanding over the next decade.
• Competitive pressures from existing therapies and high manufacturing costs pose challenges; however, technological innovations and strategic partnerships can unlock new opportunities.
• The global thrombosis management market is expanding, with recombinant antithrombin positioned as a high-value, specialized therapy in the evolving landscape of biologics.
• Continued investment in R&D and careful market access planning are essential for maximizing financial returns and clinical impact.

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FAQs

1. What are the primary clinical advantages of recombinant antithrombin over plasma-derived products?
Recombinant antithrombin reduces risks of pathogen transmission, offers consistent potency, and ensures reliable supply—addressing safety concerns and manufacturing limitations associated with plasma-derived therapies.

2. Which regulatory agencies are most likely to influence the approval pathway for recombinant antithrombin?
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the primary regulators, with pathways favoring biologics and orphan drug designations that can expedite market entry.

3. How does the current competitive landscape impact the commercial prospects of recombinant antithrombin?
Established plasma-derived products dominate the market, creating high entry barriers. However, increasing safety and efficacy data, combined with regulatory support, can facilitate adoption of recombinant variants in niche indications.

4. What factors could accelerate the financial growth of recombinant antithrombin?
Successful clinical trials demonstrating superiority or non-inferiority, regulatory approval, payer acceptance, and strategic partnerships are central to accelerating revenue growth.

5. Are there significant patent protections or pipeline developments that could influence future market exclusivity?
Pending patents on recombinant expression systems and formulations may provide market exclusivity. Additionally, pipeline innovations, such as biosimilar derivatives, could influence competition in subsequent years.

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References

[1] MarketWatch, "Global Antithrombin Market Size Forecast," 2022.
[2] Clinical Trials.gov, "Recombinant Antithrombin Clinical Trial Data," 2023.
[3] EMA, "Biologics Regulatory Pathways," 2023.
[4] Deloitte Insights, "Biopharmaceutical Investment and Innovation Trends," 2022.
[5] Allied Market Research, "Biologics in Coagulation Disorders," 2022.