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		2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2033-03-04	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2033-03-04	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		2034-07-29	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2035-07-20	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2037-02-27	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2038-03-15	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2002-05-05	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2007-05-06	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2013-07-29	Patent claims search

International Patents for EVITHROM

Country	Patent Number	Estimated Expiration
Brazil	122022012099
Canada	2859784
Russian Federation	2015126540
Israel	277033
World Intellectual Property Organization (WIPO)	2013096176
South Korea	20210046699
Japan	2016505543

Market Dynamics and Financial Trajectory for the Biologic Drug: EVITHROM

Last updated: September 26, 2025

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Introduction

The biologic drug EVITHROM, developed as a topical thrombin formulation, addresses hemostatic needs across surgical and wound management domains. As a biologic, EVITHROM operates within a highly competitive landscape characterized by evolving regulatory frameworks, technological advances, and shifting clinical practices. Understanding its market dynamics and projected financial trajectory offers valuable insights for stakeholders, from pharmaceutical companies to investors and healthcare providers.

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Overview of EVITHROM and Its Therapeutic Niche

EVITHROM is a topical thrombin product designed to promote clot formation and control bleeding during surgical procedures or wound care. Derived from biologic sources, thrombin accelerates coagulation by catalyzing the conversion of fibrinogen to fibrin, facilitating hemostasis. The product's niche includes cardiovascular surgeries, dental procedures, and trauma management. Its efficacy and safety profile position it as an alternative to traditional hemostatic agents, especially in complex or bleeding-prone surgeries.

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Market Landscape and Competitive Position

Market Size and Growth Drivers

The global surgical hemostats market, encompassing biologic agents like EVITHROM, is projected to grow at a compound annual growth rate (CAGR) of approximately 7-9% through 2030, driven by increasing surgical procedures worldwide and rising prevalence of traumatic injuries and cardiovascular diseases [1].

Key growth drivers include:

• Rising demand for minimally invasive surgeries, necessitating superior hemostatic agents.
• Expanding geriatric population with higher bleeding risks.
• Innovations leading to improved biologic hemostats’ safety and efficacy profiles.
• Regulatory approvals expanding product indications.

Competitive Dynamics

EVITHROM competes in a segment dominated by established biologic thrombin products from global players such as Ethicon, Pfizer, and Takeda. These competitors benefit from extensive R&D investments and established distribution channels. However, EVITHROM's success hinges on differentiators such as:

• Manufacturing scalability and consistent biologic activity.
• Cost competitiveness.
• Ease of application and compatibility with various surgical environments.
• Proven safety and efficacy.

Emerging biosimilars or recombinant thrombin alternatives pose additional competition, potentially impacting market share and pricing.

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Regulatory and Reimbursement Environment

Robust regulatory pathways govern biologic drugs, emphasizing safety, purity, and efficacy. In the U.S., the Food and Drug Administration (FDA) classifies thrombin products as sterile hemostats, requiring rigorous clinical trials and post-market surveillance.

Reimbursement policies from entities like Medicare and private insurers significantly influence EVITHROM’s adoption rate. Favorable reimbursement can expedite market penetration, whereas reimbursement hurdles may hinder growth. Currently, reimbursement variability exists globally, with higher acceptance in developed markets like the U.S. and Europe.

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Pricing Strategies and Market Penetration

Pricing strategies for EVITHROM depend on manufacturing costs, competitive positioning, perceived value, and payer negotiations. As a biologic, EVITHROM involves complex manufacturing, often leading to higher prices compared to synthetic hemostats.

Market penetration advances through:

• Strategic partnerships with surgical device companies.
• Demonstration of superior clinical outcomes.
• Cost-effectiveness analyses favoring its broader adoption.
• Education campaigns targeting surgeons and hospital procurement teams.

Pharmacovigilance and Safety Profile

Biologics inherently carry immunogenicity risks. Ongoing pharmacovigilance programs ensure early detection of adverse reactions, which can influence market confidence and post-market approval status. Positive safety profiles support sustained market growth.

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Financial Trajectory Forecast

Revenue Projections

Assuming favorable clinical trial results, regulatory approvals, and effective commercialization, EVITHROM can experience robust revenue growth over the next decade. For instance:

• Short-term (1-3 years): Initial adoption in key markets, capturing 5-10% of the surgical hemostats segment, generating modest revenue.
• Medium-term (4-7 years): Expansion into additional indications and regions, with projected CAGR of approximately 15-20%.
• Long-term (8-10 years): Achieving substantial market share (~20-30%) in major markets, with revenues potentially exceeding hundreds of millions USD annually.

These projections depend on factors such as market acceptance, competitive responses, and advancements in biologic manufacturing technology.

Cost and Profitability Considerations

Initial R&D expenses, including clinical trials, may be substantial; however, mature biologic products benefit from high margins due to perceived clinical value. Economies of scale in manufacturing and strategic partnerships could improve profitability margins, making EVITHROM a lucrative asset.

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Market Challenges and Risks

• Regulatory delays: Prolonged approval timelines can impact revenue realization.
• Pricing pressures: Competitive pricing and biosimilar entries could erode margins.
• Manufacturing complexities: Ensuring consistent biologic activity demands sophisticated facilities.
• Market acceptance: Dependence on surgeon and hospital adoption rates may slow growth.

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Strategic Recommendations

To maximize EVITHROM’s market potential, stakeholders should:

• Invest in clinical studies demonstrating superior outcomes.
• Forge alliances with surgical device manufacturers for integrated solutions.
• Educate healthcare professionals emphasizing EVITHROM’s benefits.
• Monitor and adapt to regulatory and reimbursement environments globally.
• Optimize manufacturing processes for scalability and cost efficiency.

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Key Takeaways

• EVITHROM operates within a burgeoning surgical hemostats market driven by technological advancements and increasing surgical procedures.
• Its success depends on differentiability, safety, cost-effectiveness, and strategic marketing.
• Competitive landscape includes entrenched players and emerging biosimilars; differentiation is critical.
• Global revenue potential is promising, with projections indicating double-digit growth over the next decade, contingent upon regulatory approval, reimbursement, and clinical acceptance.
• Addressing manufacturing, regulatory, and market access risks will be vital to realizing EVITHROM’s full financial trajectory.

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FAQs

1. What differentiates EVITHROM from other thrombin-based hemostats?
   EVITHROM’s differentiation hinges on its biologic origin, manufacturing process, safety profile, and ease of application, potentially leading to improved clinical outcomes.

2. How does regulatory approval influence EVITHROM's market potential?
   Regulatory approvals in key markets like the U.S. and Europe enable commercial launch and reimbursement, significantly impacting sales traction and revenue streams.

3. What are the major challenges facing EVITHROM's market growth?
   Challenges include competition from biosimilars, pricing pressures, manufacturing complexities, and variability in healthcare adoption practices.

4. What is the outlook for EVITHROM’s revenue growth?
   With strategic positioning and acceptance, EVITHROM could see revenues grow steadily at a CAGR of 15-20% over the next five to ten years.

5. How can stakeholders mitigate risks associated with biologic manufacturing?
   Investing in state-of-the-art manufacturing facilities, rigorous quality control, and supply chain diversification are critical to mitigating manufacturing risks and ensuring product consistency.

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References

1. Grand View Research, "Surgical Hemostats Market Size, Share & Trends Analysis," 2022.