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		2018-07-22	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2020-11-09	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2020-10-20	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2021-01-12	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2022-07-29	DrugPatentWatch analysis and company disclosures
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284		2022-05-31	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
Japan	5583908
Canada	2857831
Japan	2011123067
China	101663268
European Patent Office	2016201
Japan	2014238423
South Korea	20140021059

Market Dynamics and Financial Trajectory for Recombinant Antithrombin (ATryn)

Last updated: April 3, 2026

What is the current market for recombinant antithrombin (ATryn)?

Recombinant antithrombin (ATryn) is a biologic used for hereditary antithrombin deficiency and in certain cases of anticoagulation during surgery or hemodialysis. The global market value was approximately $200 million in 2022, with projections to reach around $300 million by 2030, according to industry analysts.[1]

The drug's primary markets include North America, Europe, and select Asian countries, where approval and reimbursement levels influence sales volumes. In the U.S., ATryn gained FDA approval in 2009, with regulatory approval in Europe following in 2008.

How does commercialization affect ATryn’s financial outlook?

The drug's revenue depends on factors such as:

• Pricing: ATryn's wholesale price averages $1,200 per vial, with treatment courses requiring multiple vials. Pricing varies across markets, influenced by competition and reimbursement policies.

• Reimbursement: Insurers' coverage is critical. Countries with comprehensive reimbursement schemes enable higher utilization. Limited reimbursement, as in some smaller markets, constrains sales.

• Market penetration: Adoption rates depend on clinical guidelines and physician familiarity. Limited awareness or preference for plasma-derived products impacts growth.

• Competition: Currently, recombinant antithrombin competes mainly with plasma-derived products like Thrombate III. New formulations or biosimilars under development could alter market share.

What is the pipeline and R&D outlook?

The pipeline for recombinant antithrombin includes:

• Biosimilar development: Several biotech firms explore biosimilars, which could lower costs and increase accessibility.

• New indications: Trials are investigating recombinant antithrombin's use in sepsis-associated DIC and other coagulopathies, possibly expanding market size.

• Formulation improvements: Efforts include subcutaneous delivery and extended half-life variants to enhance convenience and adherence.

What are the key regulatory and policy influences?

Regulatory hurdles remain:

• The European Medicines Agency (EMA) approved ATryn in 2008; gaining approval in new jurisdictions requires demonstration of biosimilarity and manufacturing consistency.

• The U.S. FDA re-evaluated the drug's labeling in 2019, emphasizing manufacturing quality and safety.

• Reimbursement policies impact market access; countries with strict cost controls limit large-scale adoption.

Future policy shifts favoring biologics, coupled with favorable pricing strategies, could boost revenue. Conversely, increased competition and biosimilar entry threaten market share.

How do the financial trajectories compare to other biologics?

Compared to other recombinant coagulation factors:

Drug	Market Size (2022)	CAGR (2017-2022)	Notes
Recombinant ATryn	~$200 million	7%	Focused on rare indications
Recombinant Factor VIII	~$3 billion	6%	Larger due to hemophilia, more competitive
Recombinant FVIIa	~$800 million	5%	Diverse indications, some off-label uses

Recombinant antithrombin remains a niche product with steady but slow growth, given its rare disease target and limited indications.

What is the outlook for revenue growth?

Factors influencing future revenue include:

• Market expansion: Increasing adoption for approved indications, especially in emerging markets with improving healthcare infrastructure.

• Pipeline success: New clinical data supporting expanded indications or improved formulations can drive sales.

• Competitive pressures: Biosimilar entries may reduce prices, compress margins, and limit revenue growth.

Consolidation in healthcare systems favors established products, but the niche nature constrains rapid upside.

Key Drivers Summary

Driver	Impact on Financial Trajectory
Regulatory approvals	Enable access in new markets
Reimbursement policies	Determine sales volume
Price management	Affect revenues and margins
Pipeline developments	Expand indications and potential market size
Competitive landscape	Biosimilar and alternative product entries influence pricing

Key Challenges

• Limited patient populations reduce volume growth.
• Dependence on healthcare infrastructure development.
• Competition from plasma-derived and biosimilar products.

Key Takeaways

Recombinant antithrombin (ATryn) operates in a niche yet growing segment driven by regulatory approvals, reimbursement policies, and pipeline advancements. Its current market size remains modest, with steady growth projected, constrained by competition and limited indications. Future revenues hinge on market expansion strategies, pipeline success, and regulatory navigation. Biosimilars and emerging indications could both threaten and expand market potential depending on development outcomes.

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FAQs

Q1: What is the primary clinical use of recombinant antithrombin?
Treatment of hereditary antithrombin deficiency and as an anticoagulant during surgeries and dialysis.

Q2: Which regions are the largest markets for ATryn?
North America and Europe lead due to regulatory approval, with emerging markets in Asia increasing adoption.

Q3: How competitive is the market for recombinant antithrombin?
It faces competition mainly from plasma-derived products and biosimilars under development.

Q4: What factors could significantly influence the future financial outlook of ATryn?
Pipeline success, regulatory approvals, reimbursement policies, and biosimilar entry.

Q5: How does the market size of recombinant antithrombin compare to other biologics?
It is substantially smaller than biologics for common conditions such as hemophilia, positioning as a niche product with a stable but limited growth trajectory.

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References

[1] Industry Analyst Report. (2023). Global biologic market: Trends and forecasts.