Last updated: September 24, 2026
Thrombin topical (recombinant), marketed as Recothrom, is a recombinant human thrombin biologic used to control bleeding during surgery when conventional surgical techniques are ineffective or impractical. Its commercial profile is mature rather than expansion-driven. The product has an established hospital-use position, but sales growth is constrained by procedure volumes, formulary competition, hospital purchasing pressure, and the availability of alternative topical hemostats.
Public filings do not provide a consistent, current standalone revenue series for Recothrom. The product’s financial trajectory is best analyzed through its ownership changes, hospital market position, regulatory status, competitive products, and exposure to biologic and procurement-related risks.
What is thrombin topical (recombinant)?
Thrombin topical (recombinant) is a genetically engineered form of human thrombin produced in a Chinese hamster ovary cell-expression system. It is applied topically to a bleeding site to convert fibrinogen into fibrin and promote clot formation. Recothrom is supplied as a sterile, lyophilized powder that is reconstituted before use. The product is available in vial sizes including 1,000, 5,000, and 20,000 international units, depending on the marketed presentation and labeling period. [1]
The product is used in surgical specialties where local hemostasis is required, including:
- General surgery
- Cardiovascular surgery
- Orthopedic procedures
- Neurosurgery
- Vascular surgery
- Plastic and reconstructive surgery
Recothrom is not a systemic anticoagulant or systemic thrombolytic. Its commercial demand is tied to operating-room activity and the use of adjunctive hemostatic products.
What is the FDA regulatory status of Recothrom?
Recothrom was approved by the U.S. Food and Drug Administration as a biologic product under Biologics License Application No. 125272. FDA approval occurred in 2008. The reference product is regulated under the Public Health Service Act rather than the small-molecule abbreviated new drug application pathway. [1][2]
| Regulatory attribute |
Status |
| Active ingredient |
Recombinant human thrombin |
| Brand |
Recothrom |
| Product category |
Topical biologic hemostatic |
| U.S. application |
BLA 125272 |
| FDA approval |
2008 |
| Administration |
Topical |
| Primary setting |
Surgical and procedural hemostasis |
| Current competitive pathway |
Biosimilar or interchangeable biologic pathway, subject to FDA requirements |
| Orange Book status |
Not treated like a conventional small-molecule NDA product |
The product’s biologic status matters commercially. A conventional generic can often enter through an ANDA after small-molecule patents and exclusivity expire. A competing recombinant thrombin product would generally require a separate biologics application, potentially supported by a biosimilar or interchangeable-product strategy.
Who owns and markets thrombin topical (recombinant)?
Recothrom originated with ZymoGenetics, a biotechnology company focused on recombinant proteins. Bristol-Myers Squibb acquired ZymoGenetics in 2010 for approximately $885 million, including assumed debt, giving BMS control of Recothrom and ZymoGenetics’ broader development portfolio. [3]
The product later moved through additional commercial ownership and licensing arrangements. Current U.S. labeling identifies Mallinckrodt Hospital Products Inc. as the manufacturer or labeling entity for Recothrom. Ownership and commercialization rights should be distinguished from the original development history because the product’s financial contribution has not been reported consistently under one corporate owner. [1]
| Period |
Commercial position |
| Before 2010 |
Developed and commercialized by ZymoGenetics |
| 2010 onward |
Included in Bristol-Myers Squibb’s acquisition of ZymoGenetics |
| Later period |
Commercial rights transferred through subsequent transactions |
| Current U.S. labeling |
Associated with Mallinckrodt Hospital Products Inc. |
How has the financial trajectory developed?
Recothrom’s historical financial trajectory reflects a specialty hospital product rather than a high-growth outpatient medicine. Revenue has been influenced by operating-room utilization, hospital contracts, product availability, and competitive bidding.
Public company filings have not maintained a uniform, separately reported Recothrom revenue line across all ownership periods. ZymoGenetics reported product revenue during the early commercialization phase, but subsequent owners generally included Recothrom within broader hospital products, specialty pharmaceuticals, or hemostasis portfolios. Current standalone sales, gross margin, and operating-profit figures are not consistently disclosed.
Financial trajectory by phase
| Phase |
Financial characteristics |
Main drivers |
| Launch and adoption |
Initial market penetration in hospital surgery |
Clinical adoption, surgeon familiarity, hospital formulary placement |
| BMS ownership |
Portfolio integration rather than independent reporting |
BMS commercial infrastructure and broader pharmaceutical priorities |
| Mature hospital product |
Stable but procedure-dependent demand |
Surgical volume, contracting, competitor discounts |
| Current mature phase |
Limited public disclosure and lower visibility |
Portfolio ownership, hospital purchasing, alternative hemostats |
The product’s economic value is concentrated in recurring hospital utilization rather than broad retail dispensing. That creates relatively predictable procedure-linked demand but limits pricing power. Hospitals frequently evaluate topical hemostats through value-analysis committees, which compare acquisition cost, application efficiency, blood-loss reduction, operating-room time, and clinical convenience.
How large is the market for topical thrombin products?
The relevant market is broader than recombinant thrombin. Hospitals can select among several topical hemostatic categories:
- Human plasma-derived thrombin
- Bovine thrombin
- Recombinant human thrombin
- Fibrin sealants
- Gelatin-based agents
- Oxidized regenerated cellulose
- Microporous polysaccharide products
- Collagen and combination hemostats
Recothrom competes most directly with topical thrombin products when the clinical requirement is enzymatic conversion of fibrinogen to fibrin. It competes indirectly with non-thrombin hemostats when surgeons can obtain adequate bleeding control through a matrix, patch, powder, sealant, or absorbable material.
Competitive products
| Product or category |
Competitive relationship with Recothrom |
| Thrombin-JMI |
Direct topical thrombin competitor; plasma-derived human thrombin |
| Bovine thrombin products |
Direct functional competitor, with different immunogenicity considerations |
| Floseal |
Indirect competitor; gelatin-thrombin matrix |
| Surgiflo |
Indirect competitor; gelatin-based hemostatic matrix |
| Tisseel and other fibrin sealants |
Indirect competitor; fibrin-based sealant |
| Surgicel |
Indirect competitor; oxidized cellulose |
| Arista and similar powders |
Indirect competitor; non-thrombin topical hemostasis |
Recothrom’s clinical positioning is supported by the absence of bovine proteins in its recombinant production process and by the use of a human thrombin sequence. That positioning can matter in institutions concerned about antibody formation or exposure to bovine-derived proteins. The commercial advantage is narrower when a hospital’s decision is driven primarily by unit price.
What patents protect thrombin topical (recombinant)?
The main intellectual-property value for Recothrom historically came from recombinant production, thrombin composition, formulation, manufacturing controls, and use in surgical hemostasis. Because Recothrom is a biologic licensed under a BLA, its protection cannot be assessed solely through the FDA Orange Book.
The FDA Orange Book is principally associated with approved drug products under NDAs and ANDAs. Recothrom’s relevant regulatory reference information is found through the FDA biologics framework and the Purple Book. [2] Patent rights may still be asserted against a competing biologic, but they are not presented in the same standardized Orange Book patent-listing format used for many small-molecule drugs.
Patent categories relevant to the product
| Patent category |
Commercial relevance |
| Recombinant thrombin sequence and expression |
Protects the biological product or its production platform |
| Cell-line and fermentation methods |
Can raise manufacturing barriers |
| Purification and viral-clearance methods |
Supports quality and regulatory consistency |
| Stabilized formulations |
May protect shelf life and reconstitution performance |
| Vial and presentation technology |
Can affect handling and hospital workflow |
| Surgical hemostasis methods |
May provide narrower method-of-use protection |
The practical patent risk is therefore different from the risk for a conventional branded tablet. A competitor may need to establish its own cell line, manufacturing process, analytical comparability package, and clinical justification even if particular composition patents have expired.
Publicly available information does not establish a single current patent expiration date that determines all U.S. competition for Recothrom. Product exclusivity, patent rights, manufacturing know-how, regulatory requirements, and commercial contracting must be evaluated together.
When does thrombin topical (recombinant) lose exclusivity?
Recothrom’s original biologic exclusivity has expired. The product was approved in 2008, and the principal commercial question is no longer the end of initial FDA exclusivity. The remaining barriers are patent scope, biosimilar development, manufacturing capability, regulatory investment, and hospital-market economics.
No conventional automatic generic-entry date applies in the same manner as a small-molecule NDA product. A competitor could pursue a biosimilar or other biologic development strategy, but FDA approval would require a sufficiently robust package addressing analytical similarity, manufacturing quality, immunogenicity, and clinical performance. [2][4]
Exclusivity timeline
| Event |
Approximate timing |
| Recothrom FDA approval |
2008 |
| ZymoGenetics acquired by BMS |
2010 |
| Original biologic exclusivity period |
Expired |
| Current market status |
Mature biologic with no established U.S. interchangeable or biosimilar competitor publicly identified in the FDA Purple Book |
| Near-term commercial exposure |
Hospital contracting and competing hemostatic technologies |
Are there Paragraph IV challenges to Recothrom?
A conventional Paragraph IV challenge is not the principal pathway for Recothrom because the product is a biologic licensed under a BLA rather than a typical small-molecule NDA. Paragraph IV certifications are associated with ANDA applicants challenging listed patents for small-molecule drug products.
A competing recombinant thrombin developer would more likely face the biologic patent-dispute framework, including the information-exchange and litigation provisions associated with the Biologics Price Competition and Innovation Act. The absence of a traditional Paragraph IV notice does not mean the product is free of patent risk. It means the legal pathway is different.
No publicly established U.S. biosimilar approval or major active patent litigation involving Recothrom has become a defining market event in the available regulatory record through the current period.
What generic and biosimilar entry risks exist?
The principal entry risk is not an immediate low-cost generic launch. It is a delayed biologic competitor that can obtain hospital formulary access through a lower acquisition price or a differentiated supply agreement.
Key entry barriers
- Recombinant-protein manufacturing capability
- Cell-line development and characterization
- Viral safety and purification validation
- Comparability and immunogenicity testing
- Sterile vial production
- Supply reliability for hospital customers
- Surgeon and pharmacy conversion costs
- Contracting with group purchasing organizations
- Patent and trade-secret diligence
A biosimilar competitor could pressure pricing without fully displacing Recothrom. Hospitals may maintain multiple thrombin products because product selection depends on procedure type, surgeon preference, inventory, and contract terms.
What litigation and settlement agreements affect Recothrom?
No major publicly documented settlement agreement or ongoing Paragraph IV litigation is established as a central commercial event for Recothrom. The product’s litigation exposure is more likely to arise from future biosimilar development, manufacturing patents, licensing disputes, product liability claims, or supply arrangements than from the conventional generic litigation cycle.
A definitive assessment of settlement economics would require a specific case docket or agreement. Public company reporting has not identified a settlement that materially reset the product’s market trajectory.
How strong is the patent estate for thrombin topical (recombinant)?
The patent estate is best characterized as a layered but aging biologic estate.
Composition and platform patents may have limited remaining commercial life depending on the specific claim and patent-family history. Manufacturing know-how can remain valuable after patent expiration, but trade secrets do not prevent an independent competitor from developing a separate process. Formulation and presentation patents may provide narrower protection and may not block a competitor using a different vial, stabilizer, or manufacturing configuration.
| Strength factor |
Assessment |
| Regulatory moat |
Moderate |
| Manufacturing complexity |
Moderate to high |
| Original biologic exclusivity |
Expired |
| Patent visibility through Orange Book |
Limited |
| Hospital switching costs |
Moderate |
| Direct generic risk |
Low |
| Biosimilar risk |
Moderate over the longer term |
| Alternative-hemostat risk |
High |
What is the revenue exposure for the current owner?
Recothrom is unlikely to represent a major share of a diversified pharmaceutical company’s consolidated revenue. The product is commercially meaningful as a hospital portfolio asset, but it does not have the revenue scale of a mass-market chronic medicine or a leading biologic in oncology, immunology, or diabetes.
Its value is more closely linked to:
- Retention of hospital contracts
- Product availability
- Manufacturing reliability
- Price realization
- Surgical procedure volumes
- Portfolio cross-selling
- Avoidance of quality or supply interruptions
The main downside scenario is gradual erosion rather than an abrupt patent cliff. A lower-priced thrombin competitor, a successful hospital-contracting strategy by an incumbent rival, or substitution by non-thrombin hemostats could reduce volume and price.
How does Recothrom compare with thrombin and fibrin-sealant competitors?
Recothrom’s main differentiation is recombinant production and human thrombin biology. Thrombin-JMI competes more directly on mechanism but differs in source and product history. Fibrin sealants and gelatin-thrombin matrices offer broader mechanical or adhesive hemostasis and can be preferred in surgical situations where a standalone thrombin solution is insufficient.
| Attribute |
Recothrom |
Plasma-derived thrombin |
Fibrin sealant |
| Mechanism |
Converts fibrinogen to fibrin |
Converts fibrinogen to fibrin |
Delivers fibrin-forming components |
| Product type |
Recombinant biologic |
Human plasma-derived biologic |
Combination biologic |
| Main use |
Topical enzymatic hemostasis |
Topical enzymatic hemostasis |
Adhesion and tissue sealing |
| Direct substitution |
High versus topical thrombin |
High versus topical thrombin |
Moderate |
| Manufacturing complexity |
High |
High |
High |
| Hospital purchasing sensitivity |
High |
High |
High |
Key Takeaways
- Recothrom is a mature recombinant thrombin biologic approved by FDA in 2008.
- Its commercial demand is tied to surgery and hospital purchasing rather than retail prescription volume.
- Original biologic exclusivity has expired, but no conventional automatic generic-entry date controls the market.
- Recothrom is not assessed through the Orange Book in the same manner as an NDA-approved small-molecule drug.
- A future competitor would likely use a biologic or biosimilar pathway rather than a traditional Paragraph IV ANDA challenge.
- The largest commercial risks are hospital price pressure, alternative topical hemostats, supply disruption, and eventual recombinant thrombin competition.
- Public filings do not provide a consistent current standalone revenue figure for Recothrom.
- The product’s residual value rests on manufacturing capability, clinical familiarity, hospital contracts, and supply reliability.
FAQs About Thrombin Topical (Recombinant)
Is Recothrom a biosimilar?
No. Recothrom is the original recombinant human thrombin reference product. A biosimilar would require separate FDA approval based on a similarity demonstration to the reference biologic.
Is Recothrom listed in the Orange Book?
Recothrom is regulated as a biologic under a BLA, so its regulatory and reference-product status is evaluated through the biologics framework rather than the standard Orange Book framework for small-molecule NDA products.
Does Recothrom have a generic version?
No conventional generic version has become an established U.S. market competitor. Any comparable recombinant product would face biologic manufacturing and FDA approval requirements.
What is the principal competitor to Recothrom?
Thrombin-JMI is the most direct branded thrombin competitor. Fibrin sealants, gelatin matrices, oxidized cellulose, collagen products, and hemostatic powders compete indirectly.
Is Recothrom still commercially relevant?
Yes. Its relevance is concentrated in hospital surgery and procedural hemostasis. Its mature-market outlook depends on formulary retention, contract pricing, supply reliability, and the pace of substitution by alternative hemostatic products.
References
- U.S. Food and Drug Administration. (2013). Recothrom thrombin topical recombinant prescribing information.
- U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products.
- Bristol-Myers Squibb Company. (2010). Bristol-Myers Squibb to acquire ZymoGenetics.
- U.S. Food and Drug Administration. (2023). Biosimilar and interchangeable biosimilar biological products.
