RECOTHROM Thrombin topical

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Mallinckrodt, a leading specialty biopharmaceutical company, today announced it closed the acquisition of the global portfolio of three commercial-stage topical hemostasis drugs from The Medicines Company. The portfolio includes RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant (Human)).

Under Mallinckrodt’s acquire to invest operating model, the company will invest in market development of RECOTHROM, PreveLeak and RAPLIXA, all innovative, highly durable hemostasis products that increase surgeons’ choices. The addition of these global hemostasis assets to the company’s Specialty Brands segment will expand Mallinckrodt’s growing hospital portfolio, including INOmax® (nitric oxide) for inhalation and THERAKOS® immunotherapy systems, and specifically augments its current OFIRMEV® (acetaminophen) injection surgical pain management offering. Products that help control bleeding are essential to surgical practice, and the market is estimated at $750 million annually in the U.S. and at least $1 billion globally.

“Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV broadens Mallinckrodt’s impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt.

Ron Lloyd, Senior Vice President and President, Hospital Therapies, said, “As we continue to further diversify our portfolio, we’re excited about the volume growth opportunity these products offer, which can expand access to patients in the hospital setting for years to come.”

RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. PreveLeak provides an ideal balance of strength and flexibility, and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. RAPLIXA is the first biologically active powdered hemostat which contains both thrombin and fibrinogen. The RAPLIXASpray™ device allows for greater versatility in administering RAPLIXA. Each of the acquired products is approved for use in the U.S. and certain European countries, with long-range market exclusivity through intellectual property protection – RECOTHROM to 2026, PreveLeak to 2028 and RAPLIXA to 2031. Only RECOTHROM is currently marketed in the United States.

For Further Information
More on the molecular diagnostics market in the US can be found in a series of reports published by iData Research encompassing the US Market for In Vitro Diagnostics. The reports covered in this suite include immunochemistry, molecular diagnostics, molecular blood donor screenings, hemostasis market, hematology market, and point of care diagnostic devices.

Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about molecular diagnostics market data or procedure data, register online or email us at [email protected] for a US Market for In Vitro Diagnostic report series brochure and synopsis.

About Mallinckrodt
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company’s core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company’s Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit

About Procedure Tracker
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