LANGHORNE, Pa., July 30, 2026
Savara Inc. announced that the European Patent Office (EPO) and the Australian Patent Office have granted patents covering the liquid formulation of MOLBREEVI, the company’s investigational inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) therapy for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The newly issued patents extend intellectual property protection for the formulation in Europe and Australia until March 2041, reinforcing Savara’s long-term commercialization strategy for its lead rare respiratory disease candidate. The announcement builds on the company’s earlier achievement in December 2025, when Savara and PARI Pharma secured a joint European patent covering the MOLBREEVI drug-device combination delivered through the proprietary eFlow® Nebulizer System, providing protection until March 2043. Together, these milestones significantly strengthen Savara’s global intellectual property estate as the company advances Phase 3 development of MOLBREEVI and prepares for potential regulatory submissions in major markets.
New Patents Strengthen Long-Term Global Intellectual Property
According to Savara, the newly granted European Patent No. 4121000 and the Australian Patent No. 62/990,810 specifically protect the liquid formulation of MOLBREEVI, creating an additional layer of exclusivity in key international markets where no approved therapies currently exist for autoimmune PAP. Kate McCabe, Chief Legal Officer of Savara, stated that these approvals strengthen the company’s growing intellectual property portfolio and provide valuable protection across important commercial territories outside the United States. She also confirmed that Savara continues to pursue equivalent U.S. patent applications, including filings covering both the liquid formulation and the drug-device combination, with the objective of establishing comprehensive worldwide patent protection. The expanded IP strategy is designed to support long-term product differentiation and maximize commercial opportunities if MOLBREEVI receives future regulatory approvals.
MOLBREEVI Advances as a Potential Therapy for Autoimmune PAP
MOLBREEVI is an investigational orally inhaled recombinant human GM-CSF therapy administered using PARI Pharma’s proprietary eFlow® Nebulizer System. The therapy is currently being evaluated in Phase 3 clinical development for the treatment of autoimmune pulmonary alveolar proteinosis, a rare lung disorder caused by antibodies that neutralize GM-CSF, preventing alveolar macrophages from clearing excess pulmonary surfactant. This accumulation impairs normal gas exchange and can lead to shortness of breath, persistent cough, fatigue, recurrent infections, lung fibrosis, and potentially lung transplantation. Recognizing the significant unmet medical need, regulatory agencies have already granted MOLBREEVI several important designations, including FDA Fast Track Designation, FDA Breakthrough Therapy Designation, FDA Orphan Drug Designation, European Medicines Agency Orphan Drug Designation, and the United Kingdom MHRA Innovation Passport and Promising Innovative Medicine (PIM) designations. These recognitions underscore the therapy’s potential to become a first-in-class treatment for patients living with autoimmune PAP.
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Patents Support Future Commercialization Strategy
The newly granted patents represent another important milestone in Savara’s broader strategy to establish a durable commercial position for MOLBREEVI across global markets. By combining formulation patents, drug-device combination protection, and ongoing international patent filings, the company aims to build a comprehensive intellectual property framework that supports future regulatory approvals, commercialization, and long-term market exclusivity. As Phase 3 clinical development continues, these patent grants further reinforce investor confidence and position Savara to expand its presence in the rare respiratory disease market. If successfully approved, MOLBREEVI has the potential to address a significant unmet medical need by offering patients with autoimmune PAP a targeted inhaled therapy designed to restore normal lung function while strengthening Savara’s leadership in rare pulmonary diseases.
Source: Savara,press release
