TISSEEL Drug Profile

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Summary for Tradename: TISSEEL

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for TISSEEL

Recent Clinical Trials for TISSEEL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Walter Reed National Military Medical Center	PHASE1
Henry M. Jackson Foundation for the Advancement of Military Medicine	PHASE1
Rion Inc.	PHASE1

See all TISSEEL clinical trials

Pharmacology for TISSEEL

Physiological Effect	Increased Coagulation Activity 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 TISSEEL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TISSEEL Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for TISSEEL Derived from Patent Text Search

No patents found based on company disclosures

TISSEEL Market Dynamics, Patent Protection, Competition, and Financial Trajectory

Last updated: October 31, 2026

TISSEEL is a mature human fibrin sealant marketed by Baxter Healthcare Corporation for surgical hemostasis, tissue sealing, and adhesion prevention. Its commercial position depends more on manufacturing scale, hospital contracting, surgeon preference, regulatory continuity, and supply reliability than on remaining patent exclusivity. FDA market exclusivity and conventional small-molecule patent barriers have largely expired, while no separately reported TISSEEL revenue is disclosed in Baxter’s public filings. [1][2]

What is TISSEEL and how does it generate revenue?

TISSEEL is a two-component fibrin sealant made from human plasma-derived proteins. The product contains fibrinogen and thrombin solutions that are combined during application to form a fibrin clot. It is used in surgical procedures where conventional methods of hemostasis are ineffective or impractical.

Product attribute	TISSEEL profile
Active biological components	Human fibrinogen and human thrombin
Dosage form	Topical surgical sealant
FDA regulatory category	Biologic product regulated through a biologics license
Primary indication	Aid to hemostasis and tissue sealing in surgery
Administration	Topical application, including spray and other approved delivery methods
Sponsor/marketer	Baxter Healthcare Corporation
Manufacturing basis	Plasma-derived biological manufacturing
Principal customers	Hospitals, ambulatory surgical centers, surgeons, group purchasing organizations
Key competitors	VISTASEAL, EVICEL, ARTISS, RECOTHROM and non-fibrin surgical hemostats

TISSEEL revenue is generated through hospital purchases, distributor sales, group purchasing contracts, and procedure-specific use in areas such as cardiovascular surgery, general surgery, orthopedics, transplant surgery, neurosurgery, and reconstructive procedures.

Its economic value is linked to operating-room workflow and the cost of managing bleeding. Hospitals may accept a higher product price when the sealant reduces transfusion risk, operative time, reoperation risk, or use of other hemostatic products.

What is the financial trajectory of TISSEEL?

Baxter does not separately disclose TISSEEL revenue, gross margin, unit volume, or geographic sales in its annual reports. The product is reported within broader surgical or medical-product categories, preventing a precise public revenue series for TISSEEL. [2][3]

The financial trajectory is therefore best assessed through commercial indicators:

1. TISSEEL is a mature hospital product with an established installed base.
2. Growth is likely tied to procedure volumes, pricing, geographic expansion, and share shifts among surgical sealants.
3. Margin protection depends on plasma procurement, fractionation yield, manufacturing utilization, cold-chain logistics, and quality compliance.
4. The product is exposed to hospital purchasing pressure and competitive contracting.
5. Revenue risk is more likely to arise from substitution and supply disruption than from imminent patent expiry.

Baxter’s public reporting groups products within larger operating segments. Those disclosures show the strategic importance of surgical products but do not identify TISSEEL’s individual contribution. Any product-level revenue estimate would therefore be a market model rather than a reported financial figure.

Financial drivers

Driver	Effect on TISSEEL
Surgical procedure volume	Increases demand, particularly in high-bleeding-risk procedures
Hospital budget pressure	Can shift purchasing toward lower-cost alternatives
Group purchasing contracts	Reduces pricing flexibility
Plasma availability	Can affect production cost and supply reliability
Product shortages	Can cause hospital switching and lost shelf position
Surgeon familiarity	Supports retention and repeat use
New delivery systems	Can improve adoption and support premium pricing
Competitor contracting	Can reduce share in large hospital systems
Regulatory compliance	Creates fixed manufacturing and quality costs
International reimbursement	Determines market attractiveness outside the United States

How large is the fibrin sealant market?

The fibrin sealant market is a subset of the broader surgical hemostats and tissue-sealants market. Market research firms generally include fibrin sealants with synthetic sealants, collagen products, gelatin products, oxidized cellulose, flowable hemostats, and mechanical devices. Reported market sizes vary substantially because vendors use different product definitions and geographic scopes.

TISSEEL competes in a narrower category than the overall surgical hemostat market. Its closest commercial competitors are other human or recombinant fibrin products. Broader alternatives include products that control bleeding through mechanical compression, matrix formation, or chemical coagulation.

The market has several structural characteristics:

• Hospitals usually maintain multiple hemostasis products rather than relying on a single agent.
• Product selection varies by specialty and bleeding site.
• Surgeons often value handling characteristics, spray performance, clot strength, and time to hemostasis.
• Clinical familiarity can outweigh modest price differences.
• Procurement departments increasingly evaluate total procedural cost rather than acquisition price alone.
• Plasma-derived products carry additional manufacturing and viral-safety requirements.

What patents protect TISSEEL?

TISSEEL’s current protection is not primarily based on a publicly visible, active product patent estate. The original composition and manufacturing patents associated with older fibrin sealant technologies are generally mature or expired.

The important protection layers are now:

• Proprietary manufacturing processes
• Plasma sourcing and donor-screening systems
• Formulation know-how
• Sterile filling and packaging
• Spray and delivery-device design
• Quality-control methods
• Regulatory documentation
• Manufacturing-site approvals
• Supplier and hospital contracts

TISSEEL is a biologic rather than a conventional small-molecule drug. Its regulatory listing is associated with FDA biologics records, including the product’s biologics license and prescribing information. It is not treated like a conventional tablet or injectable small molecule listed through an NDA patent-certification framework.

Does TISSEEL have Orange Book patents?

TISSEEL should not be analyzed as an Orange Book patent product in the same manner as a conventional NDA drug. The FDA’s Orange Book primarily identifies approved drug products and associated patent and exclusivity information for the Hatch-Waxman framework. Biologic reference products are generally evaluated through the Purple Book and the Public Health Service Act biosimilar pathway. [4][5]

The commercial consequence is significant:

• There is no standard Orange Book patent-expiry date that defines TISSEEL generic entry.
• A competitor would not normally enter through a conventional ANDA Paragraph IV challenge to TISSEEL.
• Market entry would require a biologic or biologic-like regulatory strategy, supported by manufacturing capability and product comparability.
• Device and formulation patents could still create litigation risk if active claims cover delivery systems or specific compositions.

When does TISSEEL lose exclusivity?

TISSEEL’s core regulatory and patent exclusivity has already matured. The product has been marketed for decades, and any original reference-product exclusivity period has expired.

There is no commercially meaningful near-term loss-of-exclusivity date comparable to a blockbuster small-molecule drug. TISSEEL’s continuing protection comes from operational barriers rather than a single statutory expiry date.

Exclusivity category	TISSEEL status
Original biologic market exclusivity	Expired
Original composition patents	Generally mature or expired
Orange Book patent protection	Not the principal protection framework
Biosimilar reference-product exclusivity	Expired based on product age
Manufacturing know-how	Potentially ongoing
Delivery-system protection	Depends on specific patents and jurisdictions
Regulatory approvals	Ongoing, provided manufacturing and quality requirements are met
Contractual hospital access	Ongoing but contestable

What generic or biosimilar entry risks exist for TISSEEL?

TISSEEL faces substitution risk, but the risk is different from traditional generic erosion.

A conventional generic could replicate a small-molecule active ingredient through an ANDA. A competing fibrin sealant would need to address biological variability, protein composition, purity, viral safety, stability, packaging, delivery, and clinical performance.

Potential entrants could use several strategies:

1. Develop a biosimilar or biologic product under the Public Health Service Act.
2. Obtain an independent biologics license based on a full development program.
3. Compete with a different fibrin-sealant formulation or delivery platform.
4. Substitute a non-fibrin hemostat with a different mechanism.
5. Target a specific surgical specialty with a lower-cost product.

The main barriers are:

• Access to suitable plasma or recombinant raw materials
• Fractionation and purification capacity
• Viral inactivation and pathogen-reduction controls
• Comparability testing
• Stability and cold-chain validation
• Sterility assurance
• Spray-device performance
• Hospital formulary adoption
• Surgeon training and clinical acceptance
• Manufacturing-site inspection readiness

For these reasons, a biosimilar threat could be technically feasible but commercially slow. The product’s mature age reduces regulatory exclusivity barriers, while manufacturing complexity limits the number of credible entrants.

Are there Paragraph IV challenges to TISSEEL?

A traditional Paragraph IV challenge is not the central entry pathway for TISSEEL. Paragraph IV litigation applies to patents listed in the Orange Book for an approved drug product. TISSEEL is a biologic, and its relevant regulatory pathway is not the standard ANDA framework.

Potential disputes could instead involve:

• Biologic similarity and regulatory approval
• Manufacturing-process patents
• Formulation patents
• Delivery-device patents
• Trade-secret misappropriation
• Patent claims covering fibrin-sealant production
• Contractual rights to plasma or distribution channels

No widely reported, product-defining Paragraph IV litigation is associated with TISSEEL’s current commercial position in the public regulatory record reviewed for this analysis.

Which companies compete with TISSEEL?

Direct fibrin-sealant competitors

Product	Company	Competitive relevance
VISTASEAL	Johnson & Johnson, through Ethicon	Human fibrin sealant competing in surgical hemostasis
EVICEL	Johnson & Johnson, through Ethicon	Fibrin sealant used in surgical bleeding control
ARTISS	Baxter	Fibrin sealant focused on adhesion prevention in plastic and reconstructive surgery
RECOTHROM	Mallinckrodt	Recombinant thrombin product, used as a component or alternative hemostatic approach

Broader surgical-hemostat competitors

Product category	Examples	Competitive effect
Flowable gelatin matrices	FLOSEAL and similar products	Compete in active bleeding and irregular surfaces
Oxidized regenerated cellulose	Surgicel products	Compete in topical hemostasis
Gelatin sponges	Various hospital products	Lower-cost mechanical and absorptive alternative
Collagen products	Collagen-based patches and powders	Compete in localized bleeding
Synthetic sealants	PEG-based and other synthetic systems	Compete where fibrin is unsuitable
Mechanical devices	Clips, staplers, energy devices	Reduce need for topical sealants in selected procedures

TISSEEL’s closest strategic comparison is with VISTASEAL and EVICEL. Its broader competitive set is much larger because hospitals can substitute based on procedure, bleeding severity, application method, cost, and availability.

How does TISSEEL compare with VISTASEAL and EVICEL?

TISSEEL, VISTASEAL, and EVICEL share a similar commercial role but differ in formulation, delivery options, labeling, manufacturing platform, and hospital positioning.

Factor	TISSEEL	VISTASEAL	EVICEL
Product class	Human fibrin sealant	Human fibrin sealant	Human fibrin sealant
Primary use	Hemostasis and tissue sealing	Surgical hemostasis	Surgical hemostasis
Manufacturer	Baxter	Ethicon/J&J	Ethicon/J&J
Key differentiation	Long commercial history and broad surgeon familiarity	Competing hospital-contracting platform	Established surgical sealant positioning
Main risk	Mature product and procurement pressure	Competitive switching	Competitive switching
Entry barrier	Complex plasma-derived manufacturing	Complex biologic manufacturing	Complex biologic manufacturing

The winner in a hospital account often depends on price, supply, formulary placement, device convenience, and surgeon preference rather than substantial differences in the underlying clinical concept.

What is the FDA regulatory status of TISSEEL?

TISSEEL is an FDA-approved biologic product. Its prescribing information identifies the product as a fibrin sealant made from human plasma-derived components. FDA labeling includes contraindications, warnings concerning intravascular application, hypersensitivity, thromboembolic risk, viral transmission, and handling requirements. [1]

The regulatory risk profile includes:

• Plasma-donor screening
• Pathogen testing and inactivation
• Manufacturing consistency
• Sterility and container closure
• Cold-chain control
• Device compatibility
• Labeling compliance
• Postmarketing safety surveillance

TISSEEL’s regulatory continuity is a commercial asset. Hospitals are reluctant to replace a long-used biologic without reliable supply, validated performance, and clear procedural advantages.

What patent litigation and settlement agreements affect TISSEEL?

No major publicly reported patent settlement is central to TISSEEL’s current market position. The absence of a conventional Orange Book estate reduces the likelihood of a standard Hatch-Waxman patent timetable.

Potential litigation exposure remains possible in three areas:

1. A competitor could assert patents covering a formulation or application method.
2. Baxter could assert manufacturing or delivery-system patents against a new entrant.
3. Parties could litigate trade secrets, supply agreements, or regulatory data use.

The lack of a visible active patent dispute does not eliminate technical or contractual barriers. It indicates that litigation is not the primary mechanism currently controlling market entry.

What geographic markets are important for TISSEEL?

The United States is commercially important because of its large surgical volume, hospital purchasing infrastructure, and established reimbursement system. Europe and other developed markets contribute through hospital procurement and distributor channels, but pricing pressure and country-specific reimbursement can be greater.

Geographic barriers include:

• National biologic approvals
• Plasma-source requirements
• Local pharmacovigilance
• Import controls
• Hospital tender systems
• Reimbursement restrictions
• Local manufacturing or release testing
• Cold-chain distribution

A competitor with an approved product in the United States may still face substantial delays entering Europe, Japan, China, or other markets because fibrin sealants require country-specific regulatory and quality approvals.

How strong is the TISSEEL patent estate?

TISSEEL’s patent estate appears weaker as a conventional exclusivity asset and stronger as an operational moat.

Protection layer	Relative strength
Original composition patents	Low due to product age
Orange Book protection	Not central
Regulatory exclusivity	Low or expired
Manufacturing know-how	Moderate to strong
Plasma sourcing	Moderate to strong
Quality systems	Strong for new entrants
Delivery technology	Product- and jurisdiction-dependent
Hospital contracts	Moderate but renewable
Brand and surgeon familiarity	Moderate
Supply reliability	Potentially strong

For valuation purposes, TISSEEL should not be underwritten as a patent-protected growth asset. It is better characterized as a mature biologic franchise supported by manufacturing know-how, regulatory history, hospital access, and brand recognition.

What are the likely generic launch scenarios for TISSEEL?

Base case: gradual competitive erosion

A competing fibrin sealant enters selected markets and gains share through lower pricing or hospital contracts. TISSEEL retains use in established accounts and specialties where surgeon familiarity is strong.

Upside case: stable or improving share

TISSEEL benefits from procedure growth, reliable supply, improved delivery systems, or competitor manufacturing disruption. Revenue remains stable despite the absence of meaningful patent exclusivity.

Downside case: substitution and contracting pressure

Hospitals consolidate purchasing, favor a lower-cost competitor, or replace fibrin sealants with flowable matrices, synthetic sealants, or mechanical hemostasis. Baxter experiences declining volume and pricing.

The most plausible erosion pattern is gradual formulary displacement rather than an abrupt generic cliff.

Key Takeaways

• TISSEEL is a mature plasma-derived fibrin sealant marketed by Baxter.
• Baxter does not separately report TISSEEL revenue or profitability.
• The product’s original patent and regulatory exclusivity have largely expired.
• Orange Book and Paragraph IV analysis is less relevant because TISSEEL is a biologic.
• Biosimilar or independent biologic entry is technically possible but manufacturing-intensive.
• The principal competitors are VISTASEAL, EVICEL, ARTISS, RECOTHROM, and broader surgical-hemostat products.
• TISSEEL’s competitive moat is based on manufacturing, quality systems, supply reliability, hospital access, and surgeon familiarity.
• Financial performance is likely mature, with exposure to surgical volumes, hospital contracting, pricing, and product substitution.
• No publicly reported patent settlement or major Paragraph IV proceeding currently defines TISSEEL’s market outlook.
• The most likely generic-entry scenario is gradual share erosion rather than a rapid patent cliff.

FAQs

Is TISSEEL a biologic or a medical device?

TISSEEL is a biologic fibrin sealant. It may be supplied with application devices, but the active product is regulated as a biologic rather than as a standalone medical device.

Can a company file an ANDA for TISSEEL?

A conventional ANDA is generally not the primary pathway for a plasma-derived fibrin sealant. A competing company would more likely pursue a biologics pathway or an independent biologics license.

Does TISSEEL have a biosimilar approved by the FDA?

No FDA-approved TISSEEL biosimilar is identified in the FDA Purple Book records reviewed for this analysis. [5]

What is the biggest commercial threat to TISSEEL?

The largest threat is hospital-level substitution driven by contracting, pricing, competitor supply reliability, and alternative hemostatic technologies. Patent expiry is not the primary current threat.

Is TISSEEL revenue material to Baxter?

TISSEEL is part of Baxter’s surgical-products portfolio, but Baxter does not publicly disclose product-level revenue. Its individual financial contribution cannot be isolated from the company’s reported segment results.

References

1. U.S. Food and Drug Administration. (2023). TISSEEL fibrin sealant human: Prescribing information. Baxter Healthcare Corporation.

2. Baxter International Inc. (2024). 2023 annual report. Baxter International Inc.

3. Baxter International Inc. (2023). 2022 annual report. Baxter International Inc.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. FDA.