EVITHROM Drug Profile

Summary for Tradename: EVITHROM

High Confidence Patents:	3
Applicants:	1
BLAs:	1

Pharmacology for EVITHROM

Physiological Effect	Increased Coagulation Factor Activity
Established Pharmacologic Class	Human Blood Coagulation Factor
Chemical Structure	Blood Coagulation Factors

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 company disclosures

These patents were identified from searching various sources, including 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 EVITHROM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EVITHROM 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
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	12,311,015	2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	9,028,851	2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	9,212,357	2033-03-04	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247	12,311,015	2044-01-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for EVITHROM 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
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	10,046,081	2034-07-29	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	10,245,348	2035-07-20	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	10,493,094	2037-02-27	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	11,008,560	2038-03-15	Patent claims search

International Patents for EVITHROM

Country	Patent Number	Estimated Expiration
Israel	280625
Brazil	112015013071
Hong Kong	1214958
Australia	2012355476

Market Dynamics and Financial Trajectory for EVITHROM

Last updated: April 15, 2026

What is EVITHROM?

EVITHROM is a topical biologic derived from human plasma, marketed as a hemostatic agent primarily for surgical and wound care uses. It is produced by Grifols, a global plasma-derived therapeutics company, and integrates plasma proteins to facilitate blood clotting and tissue healing.

Market Overview

The global hemostatic agents market was valued at USD 4.9 billion in 2022 and is projected to reach USD 8.3 billion by 2030, growing at a compound annual growth rate (CAGR) of around 6.2% between 2023 and 2030 (Grand View Research, 2023).

Key Market Segments

• Product Type: Fibrin sealants, blood components, topical hemostats.
• Application: Surgical procedures (cardiovascular, orthopedic, general surgery), trauma management, wound care.
• End-User: Hospitals, ambulatory surgical centers, clinics.

Drivers

• Surge in surgical procedures due to aging populations and increasing chronic conditions.
• Rising adoption of biologic products over synthetic alternatives, driven by safety profiles.
• Technological advancements improving efficacy and shelf-life.

Challenges

• High production costs related to plasma harvesting.
• Stringent regulatory environment for biologics.
• Competition from synthetic and recombinant hemostatic agents.

EVITHROM’s Market Position

EVITHROM operates within a niche segment of plasma-derived topical hemostats, competing with other biologics like Evicel (Ethicon) and Tisseel (Baxter). While specific sales figures are proprietary, Grifols reports that plasma-derived products constitute approximately 20% of its total revenue, with EVITHROM accounting for a minor but growing segment.

Regulatory Status

• Approved by FDA under 510(k) clearance in the U.S.
• Available in Europe under CE marking.
• Undergoing post-marketing studies to expand indications.

Distribution and Pricing

• Distributed mainly in North America and Europe.
• Price per unit varies by application and volume, typically between USD 200 to USD 500 per application.

Financial Trajectory

Revenue Trends

• Grifols reports that plasma-derived therapeutics, including hemostats, generated about EUR 2 billion (~USD 2.2 billion) in 2022.
• EVITHROM contributes a small proportion, with estimations placing its revenues between EUR 30 million (USD 33 million) and EUR 50 million (USD 55 million) annually.

Growth Outlook

• Market penetration expected to increase owing to new surgical indications.
• R&D investments targeting enhanced formulations and broader indications.
• Strategic collaborations with surgical device companies to expand usage.

Investment Considerations

• Production costs driven by plasma collection; scalability hinges on plasma donor availability.
• Regulatory barriers remain manageable in established markets but could impede rapid expansion in emerging markets.
• Competitive pressure from recombinant thrombin and synthetic agents could pressure margins.

Future Revenue Potential

• Market analysts project that EVITHROM’s share could reach USD 100 million by 2030 if market penetration doubles, assuming stable pricing and expanding indications.
• Approvals for pediatric and trauma indications could substantially increase revenue streams.

Competitive Landscape

Product Name	Manufacturer	Type	Indication	Status
EVITHROM	Grifols	Plasma-derived topical hemostat	Surgical and wound care	Approved
Evicel	Ethicon	Fibrin sealant	Surgical hemostasis	Approved
Tisseel	Baxter	Fibrin sealant	Surgical and trauma hemostasis	Approved

Policy and Reimbursement Environment

• U.S. Medicare and private insurers reimburse EVITHROM based on procedure codes for surgical hemostats.
• European coverage varies, with national health systems setting reimbursement rates.
• Reimbursement practices influence market adoption and pricing strategies.

Key Takeaways

• EVITHROM operates in the growing sector of plasma-derived, biologic topical hemostats, with a projected CAGR of approximately 6% from 2023 to 2030.
• Sales are constrained by high production costs and market penetration barriers but are bolstered by increasing surgical procedures.
• Revenue estimates for EVITHROM range from USD 33 million to USD 55 million annually, with potential to double if indications expand.
• Competitive landscape includes fibrin sealants and synthetic agents, with EVITHROM positioned as a safe, effective biologic alternative.
• Strategic partnerships and regulatory approvals are crucial for expanding its market footprint.

FAQs

1. What market factors could accelerate EVITHROM’s growth?
Increased adoption of plasma-derived biologics, expansion into new surgical indications, and improvements in plasma collection infrastructure.

2. How does EVITHROM compare cost-wise to synthetic hemostats?
EVITHROM generally costs more due to plasma sourcing and complex manufacturing but offers a favorable safety profile.

3. What regulatory hurdles could impact EVITHROM?
Delays or rejections in gaining approval for new indications or in emerging markets could limit growth.

4. Which regions present the highest growth opportunities?
Emerging markets in Asia and Latin America, where demand for surgical hemostats is rising and regulatory pathways are evolving.

5. What is the outlook for competition from recombinant and synthetic agents?
While cost-effective, these alternatives may lack the safety profiles and bioactivity of plasma-derived products, supporting EVITHROM’s niche until biosimilar competition develops.

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References

[1] Grand View Research. (2023). Hemostatic agents market size, share & trends analysis report.

[2] Grifols. (2022). Annual Report.

[3] U.S. Food and Drug Administration. (2022). Medical device approvals and clearances.