Who Owns Thrombate III?
Thrombate III is owned by Grifols, S.A. (Bolsa de Madrid: GRF; Nasdaq ADR: GRFS), a Spanish plasma-derived medicines company headquartered in Sant Cugat del Valles, Catalonia. Grifols acquired the product through its 2011 purchase of Talecris Biotherapeutics for approximately $4 billion. In November 2025, Thrombate III became the only antithrombin concentrate approved in the US for both adults and children with hereditary antithrombin deficiency.
Parent Company
Acquired
2011
Status
Publicly Traded
Thrombate III Timeline
Who Owns Thrombate III?
- Parent Company: Grifols, S.A.
- Ownership Type: Wholly owned
- Acquisition Year: 2011
- Company Type: Publicly Traded
- Stock Ticker: Bolsa de Madrid: GRF
| Brand | Parent Company | Ownership Type |
|---|---|---|
| Thrombate III | Grifols, S.A. | Wholly owned |
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History of Thrombate III
- Founded: 1991
- Founders: Talecris Biotherapeutics predecessor companies
- Acquired by Grifols, S.A.: 2011
Thrombate III received its initial United States approval in 1991 as a lyophilized human antithrombin III concentrate, making it the first antithrombin replacement therapy cleared by the FDA for patients with hereditary antithrombin deficiency. Antithrombin is a natural blood protein that inhibits clotting; people born with deficient levels face sharply elevated risk of deep vein thrombosis, pulmonary embolism, and other thromboembolic events, particularly around surgery and childbirth.
The product was developed within the plasma fractionation industry that Bayer's biological division helped build in the United States. The North Carolina plasma business passed through corporate restructuring into Talecris Biotherapeutics, which operated the Research Triangle Park fractionation plant and held the Thrombate III biologics license through the 2000s.
Grifols acquired Talecris in 2011, and the product has remained in continuous production at the Research Triangle Park facility since. For more than three decades, Thrombate III has been the standard replacement therapy for hereditary antithrombin deficiency in the US, used both for treatment and prevention of thromboembolism and for surgical and obstetric prophylaxis.
The most significant recent development came on November 18, 2025, when Grifols announced FDA approval of an expanded indication covering pediatric patients with hereditary antithrombin deficiency. The extension, based on data extrapolation from adult clinical trials, made Thrombate III the first and only antithrombin concentrate approved for both adults and children with the condition, closing a treatment gap in a rare pediatric population.
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Off-label, antithrombin concentrates including Thrombate III have been used in some transplant protocols for hepatic veno-occlusive disease prophylaxis and treatment, alongside or instead of the approved therapy defibrotide, though that use sits outside the product's formal indication.
About Grifols, S.A.
What does Grifols do?
Grifols produces medicines derived from human blood plasma. The company collects plasma at more than 400 donation centers, fractionates it into therapeutic proteins, and sells treatments for immune deficiencies, bleeding disorders, and critical care in more than 110 countries. It also operates a transfusion diagnostics business.
Is Grifols publicly traded?
Yes. Grifols shares trade on the Spanish stock exchanges under ticker GRF, with non-voting preferred shares under GRF.P. American Depositary Receipts trade on Nasdaq under GRFS. The company is a constituent of the IBEX 35 index.
Who founded Grifols?
Hematologist Josep Antoni Grifols i Roig founded a clinical laboratory in Barcelona in 1909. His sons developed the plasma fractionation business from the 1940s onward. The founding family still holds a significant shareholding and board representation.
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Where is Grifols headquartered?
Grifols is headquartered in Sant Cugat del Valles, Catalonia, Spain, just outside Barcelona. Its largest operational hub outside Spain is in Research Triangle Park, North Carolina, where subsidiary Grifols Therapeutics manufactures plasma medicines including Thrombate III.
What is Grifols' revenue?
For fiscal year 2025, Grifols reported net revenue of EUR 7,524 million, up 7.0 percent at constant currency. Adjusted EBITDA was EUR 1,825 million and group profit was EUR 402 million, more than double the prior year.
Does the Grifols family still control the company?
The family holds a substantial minority stake and board representation, giving it effective influence over strategy, but the company is publicly listed with a majority free float. A 2024 attempt by the family and Brookfield to take Grifols private was abandoned before a formal offer was made.
What happened with Gotham City Research?
In January 2024, short seller Gotham City Research accused Grifols of misreporting debt and earnings. The stock fell sharply before recovering partially. Grifols denied the claims, its auditors confirmed the accounts, and Spain's regulator fined Gotham for market manipulation in 2025.
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- Founded: 1909
- Headquarters: Sant Cugat del Valles, Catalonia, Spain
- Company Type: Publicly Traded
- Stock: Bolsa de Madrid: GRF
- Revenue: EUR 7,524 million (FY2025)
- Employees: Approximately 25,250
Where Is Thrombate III Made / Based?
- Headquarters: Research Triangle Park, North Carolina, United States
- Manufacturing / Operations: United States
Thrombate III Categories & Tags
Thrombate III Recalls & Controversies
Thrombate III has no record of major safety recalls or withdrawn approvals in FDA records. Its safety profile reflects both the therapeutic need and the plasma-derived product class: labeled risks include hypersensitivity reactions and the theoretical risk inherent to human plasma derivatives, which the product addresses through donor screening, heat treatment, and nanofiltration.
The product's principal controversy is indirect. Off-label use of antithrombin concentrates in settings such as cardiac surgery and transplant protocols has drawn clinical debate over efficacy evidence, since trial data outside the hereditary deficiency indication is limited. Physicians weighing off-label use balance the drug's physiological rationale against sparse randomized evidence.
Plasma-derived products broadly face periodic scrutiny over donor compensation practices and supply security, issues that apply to Grifols' collection network as to the whole industry, rather than to Thrombate III specifically.
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Thrombate III Ownership: Pros & Cons
Advantages
- +Only FDA-approved antithrombin concentrate for hereditary antithrombin deficiency
- +Sole product approved for both adult and pediatric patients since November 2025
- +Over three decades of established clinical use and physician familiarity
- +Backed by Grifols' plasma collection network and fractionation scale
- +Orphan-class pricing power within a niche indication
Considerations
- -Rare indication caps commercial scale within the parent portfolio
- -Off-label competition from heparin prophylaxis and plasma products
- -Dependent on Grifols' US plasma supply chain for raw material
- -Revenue not broken out publicly, limiting visibility into performance
- -Parent's high debt load historically constrained niche product investment
Frequently Asked Questions About Thrombate III
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Sources & Further Reading
Competitors to Thrombate III
These competing brands operate in the same categories and provide similar products or services. Compare key attributes to understand market positioning and competitive landscape.
| Brand | Parent Company | Country | Founded | Market Position | Primary Market | Gender Target |
|---|---|---|---|---|---|---|
| Jazz Pharmaceuticals | Ireland | 2013 | Mass market | Global | All Genders | |
| United Therapeutics | United States | 2002 | Mass market | Global | All Genders |
Learn More About Competitors
Healthcare PharmaceuticalsDefitelio
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Prescription medication for treating hepatic veno-occlusive disease (sinusoidal obstruction syndrome) following hematopoietic stem-cell transplantation, marketed by Jazz Pharmaceuticals.
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Infused treprostinil medication for pulmonary arterial hypertension, developed and sold by United Therapeutics since its 2002 FDA approval.
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Competitive Analysis
Market Positioning: Thrombate III competes with 2 brands in the same categories, ranging from mass market to luxury positioning.
Geographic Distribution: Competitors are headquartered across multiple regions, indicating global competition in this market segment.
Brand Heritage: Competitor brands range from established heritage brands to newer market entrants, with founding years spanning several decades.
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Grifols, S.A. Stock Information
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