CROSSEAL, EVICEL Drug Profile

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Summary for Tradename: CROSSEAL, EVICEL

High Confidence Patents:	8
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 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 CROSSEAL, EVICEL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CROSSEAL, EVICEL 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	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,634,473	2040-03-10	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,857,564	2037-12-13	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,957,324	2041-05-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for CROSSEAL, EVICEL Derived from Patent Text Search

No patents found based on company disclosures

International Patents for CROSSEAL, EVICEL

Country	Patent Number	Estimated Expiration
Australia	2012360048
Brazil	112014016193
Canada	2861722

CROSSEAL and EVICEL Market Dynamics, Financial Trajectory, and Biologic Exclusivity

Last updated: November 5, 2026

CROSSEAL and EVICEL are plasma-derived human fibrin sealants used to support surgical hemostasis when conventional methods are ineffective or impractical. Both originated with Omrix Biopharmaceuticals and became part of Johnson & Johnson through its 2008 acquisition of Omrix. EVICEL became the commercially durable product. CROSSEAL has a materially weaker commercial position and is listed by FDA as discontinued. Neither product has publicly disclosed standalone revenue, so financial analysis must rely on portfolio-level reporting, regulatory status, surgical demand, and competitive positioning.[1-4]

What are CROSSEAL and EVICEL used for?

CROSSEAL and EVICEL are biologic surgical sealants containing human fibrinogen and human thrombin. When combined at the surgical site, the components form a fibrin clot that supports hemostasis.

Product	Active components	Sponsor or commercial owner	Primary U.S. use	Commercial position
CROSSEAL	Human fibrinogen and human thrombin	Omrix Biopharmaceuticals, later associated with Johnson & Johnson	Surgical hemostasis	FDA-listed discontinued product
EVICEL	Human fibrinogen and human thrombin	Omrix, later Ethicon and Johnson & Johnson	Adjunctive hemostasis in vascular surgery, abdominal and pelvic surgery, and parenchymal tissue surgery	Established marketed product

EVICEL is administered as a two-component fibrin sealant. Its FDA label covers use in adults when control of bleeding by conventional surgical techniques, including sutures, ligatures, and cautery, is ineffective or impractical.[1]

CROSSEAL had a comparable clinical concept but did not develop the same durable commercial footprint. Its discontinuation reduced direct product overlap within Johnson & Johnson’s fibrin-sealant portfolio.

What is the FDA regulatory status of CROSSEAL and EVICEL?

EVICEL received FDA approval in 2007 under biologics license application BLA 125060. It remains a regulated biologic and prescription surgical product, with manufacturing, viral safety, donor screening, and lot-release requirements.[1]

CROSSEAL received FDA approval under a separate biologics license application in the early 2000s. FDA’s Drugs@FDA database identifies the product as discontinued. Discontinuation does not by itself establish a safety withdrawal or product recall. It generally indicates that the product is no longer being marketed or that the sponsor has stopped commercial distribution.[2]

FDA status comparison

Regulatory issue	CROSSEAL	EVICEL
Product type	Human fibrin sealant	Human fibrin sealant
Approval pathway	Biologics license application	Biologics license application
FDA marketing status	Discontinued listing	Active marketed product
Reference-product relevance	Limited because commercial supply is discontinued	Relevant for biologic competition and follow-on development
Main regulatory burden	Plasma sourcing, pathogen reduction, consistency, sterility	Same, plus ongoing postmarketing and manufacturing obligations

The products are not interchangeable with conventional topical hemostats, synthetic sealants, oxidized cellulose, gelatin matrices, or recombinant thrombin. Product selection depends on the bleeding site, surgical specialty, delivery format, hospital protocol, and procurement contract.

When did CROSSEAL and EVICEL lose exclusivity?

CROSSEAL and EVICEL do not have a simple small-molecule Hatch-Waxman exclusivity profile. Their protection depends on a combination of biologics exclusivity, product-specific patents, manufacturing know-how, plasma supply, regulatory requirements, and hospital purchasing relationships.

EVICEL was approved before the Biologics Price Competition and Innovation Act’s 12-year reference-product exclusivity framework was implemented in its current form. The product therefore does not fit neatly into the modern reference-biologic timetable applicable to products approved after March 23, 2010.[5]

Patent and exclusivity assessment

Protection layer	CROSSEAL	EVICEL
U.S. biologic exclusivity	Historical approval-era protection largely expired	Historical approval-era protection largely expired
Formulation patents	No commercially important active estate publicly established	Potentially relevant, but no publicly disclosed patent barrier is known to prevent competition indefinitely
Method-of-use patents	Possible historical coverage	Label and procedure-specific claims may exist, but do not fully prevent competing hemostats
Manufacturing protection	High relative importance	High relative importance
Plasma and donor network	Commercially important	Commercially important
Regulatory know-how	Material	Material
Practical entry barrier	Discontinued product has little standalone value	Moderate-to-high for a fully substitutable human fibrin sealant

The absence of a dominant patent barrier does not mean rapid generic erosion. A follow-on biologic fibrin sealant would need to establish comparability, manufacturing consistency, viral safety, immunogenicity controls, and adequate clinical and regulatory support.

How strong is the EVICEL patent estate?

EVICEL’s commercial defensibility is stronger at the manufacturing and supply-chain level than at the level of a single blocking patent.

Human fibrin sealants rely on controlled collection and qualification of plasma, fractionation, purification, viral inactivation or reduction, formulation, aseptic filling, and validated storage. These processes create operational barriers that are difficult to replicate even when the underlying active ingredients are established.

The primary sources of competitive protection are:

• qualified plasma and donor networks;
• validated pathogen-reduction procedures;
• manufacturing scale and batch consistency;
• regulatory history;
• surgeon familiarity;
• hospital formulary placement;
• integrated distribution through Ethicon and Johnson & Johnson;
• evidence supporting use across multiple surgical settings.

A competitor can produce a similar fibrin matrix but still face a lengthy path to routine hospital adoption. Hospitals evaluate not only hemostatic performance but also application time, packaging, shelf life, adverse-event profile, staff training, and total procedural cost.

What formulations and delivery systems are protected by EVICEL?

EVICEL is supplied as a two-component fibrin sealant that is mixed and applied through a dedicated delivery system. The delivery format matters because fibrin sealants must be applied rapidly and accurately to active bleeding sites.

Commercial differentiation can arise from:

• spray versus drip application;
• dual-syringe or dual-cartridge systems;
• applicator length and surgical access;
• readiness time;
• storage and thawing requirements;
• dose control;
• compatibility with open and minimally invasive procedures.

These characteristics can create device, packaging, and combination-product barriers even when the underlying fibrinogen and thrombin chemistry is not novel. The commercial value of the delivery system is therefore linked to operating-room workflow rather than only to active ingredients.

CROSSEAL’s product-level formulation and delivery claims have limited current commercial importance because the product is discontinued. EVICEL retains value from its established formulation, validated manufacturing process, and integration with Ethicon’s surgical portfolio.

What market dynamics affect CROSSEAL and EVICEL?

The fibrin-sealant market is driven by procedural volume, blood-conservation initiatives, complex surgery, minimally invasive procedures, and demand for adjunctive hemostasis.

Demand drivers

Cardiovascular, vascular, general, hepatobiliary, transplant, orthopedic, and gynecologic procedures can require adjunctive hemostatic products. Demand tends to rise when:

• bleeding is diffuse or difficult to suture;
• conventional cautery is unsuitable;
• the surgical field is wet or anatomically constrained;
• blood-product use must be reduced;
• operating-room time has high economic value;
• surgeons prefer a familiar product with predictable handling.

Demand constraints

Fibrin sealants face pressure from lower-cost alternatives, including gelatin-thrombin matrices, oxidized regenerated cellulose, collagen products, polyethylene glycol sealants, cyanoacrylates, and topical thrombin products.

Procurement departments also push hospitals toward bundled contracts. A supplier with a broad surgical portfolio can use pricing, distribution, and contracting leverage across multiple categories. This favors Ethicon and other large surgical suppliers over a standalone discontinued product.

How does EVICEL compare with competing surgical hemostats?

Product category	Representative products	Main advantage	Main limitation
Human fibrin sealant	EVICEL, TISSEEL	Natural fibrin clot and broad surgical familiarity	Human plasma supply, cold-chain and handling requirements, cost
Fibrin sealant with synthetic or animal-derived components	Various regional products	Different formulation and supply options	Product-specific safety and handling considerations
Gelatin-thrombin matrix	Floseal and similar products	Useful in diffuse bleeding and cavity filling	Swelling, volume, and tissue-specific limitations
Oxidized cellulose	Surgicel and similar products	Low cost and easy availability	Less effective for some high-flow bleeding
Recombinant thrombin	RECOTHROM	No human plasma-derived thrombin	Requires a fibrinogen source or different hemostatic mechanism
Polyethylene glycol sealant	Surgical sealant products	Mechanical sealing and some minimally invasive uses	Tissue indication and swelling limitations

EVICEL competes on clinical familiarity, human fibrin chemistry, surgical workflow, and the Ethicon commercial platform. It does not win every procedure. Lower-cost topical agents can be preferred for routine low-volume bleeding, while fibrin sealants are more valuable when rapid local clot formation is needed.

What is the financial trajectory of CROSSEAL and EVICEL?

No public filing provides audited standalone revenue, gross margin, unit volume, or operating profit for either CROSSEAL or EVICEL. Johnson & Johnson reports primarily by business segment and does not generally break out individual surgical-hemostat products.[3,4]

CROSSEAL financial trajectory

CROSSEAL’s financial trajectory is best characterized as:

1. initial commercialization following FDA approval;
2. limited or declining market presence;
3. discontinuation from the U.S. market;
4. no meaningful current standalone revenue contribution.

Because the product is discontinued, its current financial value is mainly residual: intellectual property, historical regulatory knowledge, manufacturing assets, and potential strategic relevance to related fibrin-sealant technology. It should not be modeled as an active revenue-generating brand unless a specific geographic market continues to sell it.

EVICEL financial trajectory

EVICEL has a more durable commercial profile. Its revenue is likely tied to:

• procedure growth;
• adoption in high-acuity surgery;
• pricing and hospital contracting;
• competition from other fibrin sealants and topical hemostats;
• availability of Ethicon’s broader surgical sales channel;
• manufacturing capacity and plasma costs.

The product’s mature-market trajectory is more likely to be stable-to-declining in heavily penetrated markets, with growth opportunities in emerging markets and procedure categories where surgical hemostat adoption remains lower.

EVICEL’s value is also strategic. A mature hemostat can support broader Ethicon account relationships, even if its standalone revenue is modest relative to Johnson & Johnson’s major pharmaceutical or medical-device franchises.

What revenue exposure does Johnson & Johnson have to EVICEL?

EVICEL is part of Johnson & Johnson’s MedTech operations, historically within Ethicon’s surgery portfolio. Johnson & Johnson reports MedTech revenue by broad franchise and geography rather than by individual products. Public annual reports therefore support portfolio-level analysis but not a precise EVICEL revenue estimate.[3,4]

The financial exposure has three characteristics:

• low transparency at the product level;
• recurring hospital demand rather than prescription-driven demand;
• margin sensitivity to plasma procurement, manufacturing yield, logistics, and contracting discounts.

EVICEL is unlikely to be a material driver of Johnson & Johnson’s consolidated earnings. Its commercial importance is greater at the surgical-franchise level, where product breadth and account access affect purchasing decisions.

Which companies are challenging EVICEL?

EVICEL faces competition from established hemostat manufacturers rather than from a single direct generic challenger.

Key competitive groups include:

• Baxter, with TISSEEL and other surgical hemostatic products;
• BD, through its surgical and hemostasis portfolio;
• Teleflex and other suppliers in adjacent surgical-hemostat categories;
• specialized biologic and topical-hemostat manufacturers;
• regional producers of fibrin sealants and plasma-derived products;
• manufacturers of synthetic sealants and gelatin-thrombin matrices.

The most credible competitive threat is substitution at the procedure level. A hospital does not need to replace EVICEL with a biosimilar fibrin sealant to reduce demand. It can replace selected uses with a different hemostatic class.

Are there Paragraph IV challenges to CROSSEAL or EVICEL?

Paragraph IV litigation is generally associated with the Hatch-Waxman abbreviated new drug application pathway for small-molecule drugs. CROSSEAL and EVICEL are biologics, so a conventional Paragraph IV challenge is not the primary legal pathway.

A competitor would more likely pursue:

• a biosimilar application under section 351(k);
• a full biologics license application;
• a competing plasma-derived product;
• a medical-device or combination-product strategy;
• patent litigation under the Biologics Price Competition and Innovation Act framework, if relevant patents remain enforceable.

No widely reported active U.S. biosimilar litigation or major settlement agreement involving EVICEL is publicly identified in the cited FDA and Johnson & Johnson materials. The lack of a reported challenge does not eliminate competition from non-biosimilar hemostatic products.

What patent litigation and settlement agreements affect EVICEL?

No major publicly reported patent litigation settlement is identified as a current market determinant for EVICEL in the cited sources. The practical legal risk is less concentrated in one Orange Book-listed patent than it would be for an oral small-molecule drug.

EVICEL is not evaluated through the same Orange Book framework used for conventional approved drugs. Biologics are tracked through the Purple Book and the applicable biologics patent-disclosure and litigation framework.[5,6]

Potential disputes would likely concern:

• composition of fibrinogen-thrombin formulations;
• spray or delivery systems;
• manufacturing processes;
• purification and viral-inactivation methods;
• method-of-use claims in specific surgical procedures;
• device compatibility and combination-product rights.

What generic entry risks exist for EVICEL?

The probability of a conventional generic launch is low because EVICEL is a biologic. The more relevant risk is competition from another approved fibrin sealant or a clinically accepted substitute.

Generic and biosimilar launch scenarios

Scenario	Probability profile	Commercial effect
Conventional ANDA generic	Low or structurally inapplicable	Minimal direct risk
351(k) biosimilar or interchangeable product	Possible but technically demanding	Price pressure and formulary competition
Competing plasma-derived fibrin sealant	Commercially credible	Moderate share erosion
Synthetic or animal-derived substitute	Already active	Procedure-specific substitution
Hospital contract displacement	High in competitive tenders	Rapid account-level volume loss
Manufacturing interruption	Material risk	Short-term supply disruption and share volatility

A biosimilar entrant would need more than ingredient matching. It would need a reliable plasma supply, validated viral safety controls, consistent fibrin-clot performance, suitable delivery technology, and hospital acceptance.

How does the geographic market affect CROSSEAL and EVICEL?

EVICEL’s commercial opportunity is concentrated in regulated markets with advanced surgical infrastructure and reimbursement systems that support adjunctive hemostatic products. The United States is strategically important because of procedure volume, specialist surgery, and Ethicon’s distribution network.

Europe and other developed markets provide additional demand but can impose tighter cost controls and tender-based purchasing. Emerging markets offer procedural growth but may have lower penetration because of price sensitivity, cold-chain requirements, and uneven access to advanced surgical products.

CROSSEAL’s discontinued U.S. status limits its geographic value. Any remaining commercial activity would need to be assessed country by country because FDA discontinuation does not automatically determine marketing status in every jurisdiction.

What is the investment outlook for CROSSEAL and EVICEL?

CROSSEAL has little direct investment value as an operating product. Its relevance is historical or technical unless rights, manufacturing capacity, or regulatory assets are transferred into another product.

EVICEL has a stable but mature asset profile:

• regulatory risk is lower than for a new biologic;
• clinical demand is recurring;
• direct product revenue is undisclosed;
• competition is broad and substitution risk is real;
• patent exclusivity is less important than manufacturing and commercial execution;
• the product is unlikely to materially change Johnson & Johnson’s consolidated growth profile.

For licensing or acquisition analysis, the most important diligence topics are current country registrations, manufacturing capacity, plasma-supply contracts, quality history, product complaints, tender pricing, hospital conversion rates, and the status of delivery-system intellectual property.

Key Takeaways

• EVICEL is the commercially durable product; CROSSEAL is listed by FDA as discontinued.
• Both products are human fibrin sealants based on fibrinogen and thrombin.
• Neither product has publicly disclosed standalone revenue or profit.
• EVICEL’s protection comes mainly from manufacturing, plasma supply, regulatory history, delivery technology, and hospital relationships.
• Conventional Paragraph IV generic risk is not the correct framework for these biologics.
• The principal competitive threat is substitution by other fibrin sealants, topical hemostats, and synthetic sealants.
• EVICEL is strategically relevant to Ethicon’s surgical portfolio but is unlikely to be a material driver of Johnson & Johnson’s consolidated financial results.
• CROSSEAL has limited current commercial value unless rights or assets remain active outside the United States.

FAQs

Is CROSSEAL still sold in the United States?

FDA records identify CROSSEAL as discontinued. It should not be modeled as a currently marketed U.S. product.

Is EVICEL a biosimilar?

No. EVICEL is an original human fibrin-sealant biologic. A future competing fibrin sealant would need to pursue an appropriate biologics pathway or a separate full approval strategy.

Does EVICEL have Orange Book patents?

EVICEL is a biologic and is not evaluated through the standard Orange Book patent-listing framework used for small-molecule drugs. The Purple Book and biologics patent procedures are more relevant.

Who owns EVICEL?

EVICEL originated with Omrix Biopharmaceuticals and became part of Johnson & Johnson after the company acquired Omrix. Ethicon is the relevant Johnson & Johnson surgical operating business.

Can a hospital replace EVICEL with a generic product?

A conventional generic substitution is unlikely because EVICEL is a biologic. Hospitals can replace it with another fibrin sealant or a different hemostatic category, subject to clinical, procurement, and regulatory requirements.

References

1. U.S. Food and Drug Administration. (n.d.). EVICEL fibrin sealant [human]: Prescribing information. FDA.

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: CROSSEAL fibrin sealant [human]. FDA.

3. Johnson & Johnson. (2008). Johnson & Johnson completes acquisition of Omrix Biopharmaceuticals. Johnson & Johnson.

4. Johnson & Johnson. (2023). 2023 annual report. Johnson & Johnson.

5. U.S. Food and Drug Administration. (2023). Purple Book: Database of licensed biological products. FDA.

6. U.S. Food and Drug Administration. (2024). Biologics Price Competition and Innovation Act of 2009. FDA.