1. FDA approved FUROSCIX for pediatric patients over 43 kg. 2. Five new patents issued for FUROSCIX ReadyFlow Autoinjector, extending IP protection. 3. Autoinjector could transform patient care by offering rapid diuretic administration. 4. Market expects regulatory approval for FUROSCIX ReadyFlow by July 2026. 5. FUROSCIX offers convenient, home-based treatment options for fluid overload.
FAQ
Why Bullish?
The FDA approval and new patents bolster product potential, enhancing revenue prospects. Similar approvals for biopharmaceutical products often lead to positive stock performance.
How important is it?
The pediatric approval and patents significantly strengthen MannKind's market position and future revenue pathways.
Why Long Term?
The implications of new patents and FDA approvals will play out over the next years. Historical cases show sustained interest in innovative biopharmaceutical products after initial approvals.
Related Companies
MannKind Corporation Announces Important Updates on FUROSCIX®
WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., December 23, 2025 – MannKind Corporation (Nasdaq: MNKD) has publicly announced significant advancements regarding its FUROSCIX® (furosemide) product line. The U.S. Food and Drug Administration (FDA) has approved the use of FUROSCIX for pediatric patients, while the U.S. Patent and Trademark Office (USPTO) has issued five new patents to safeguard the innovative FUROSCIX ReadyFlow™ Autoinjector.
FDA Approval for Pediatric Use of FUROSCIX
The FDA has approved a supplemental New Drug Application (sNDA) for FUROSCIX® (furosemide), allowing its use in pediatric patients weighing 43 kg or more. Previously, FUROSCIX was authorized only for adults suffering from edema linked to chronic heart failure (CHF) and chronic kidney disease (CKD). This recent approval satisfies the requirements set forth by the Pediatric Research Equity Act.
Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation, expressed enthusiasm about the approval, stating, “We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria.”
Intellectual Property Enhancements for FUROSCIX ReadyFlow™ Autoinjector
The five newly issued patents by the USPTO protect the FUROSCIX ReadyFlow Autoinjector, covering high-concentration liquid formulations of furosemide and related treatment methodologies. This intellectual property protection is expected to extend until 2040. If the ReadyFlow autoinjector receives FDA approval, these patents will be included in the FDA’s Orange Book.
MannKind’s robust patent portfolio not only complements the existing patents for FUROSCIX but also solidifies the company's market positioning related to this drug-device combination.
Potential Impact of FUROSCIX ReadyFlow™ Autoinjector
MannKind has also revealed that the FDA has accepted its sNDA for the FUROSCIX ReadyFlow Autoinjector, aimed at mitigating edema in adult patients with CHF or CKD. This application has a PDUFA target action date of July 26, 2026.
If approved, the FUROSCIX ReadyFlow Autoinjector will provide patients with an IV-equivalent diuretic dose in under 10 seconds, allowing them to manage fluid buildup in the comfort of their homes instead of hospitals. This aligns with prior approvals of the FUROSCIX On-body Infusor, which was initially approved in 2022 for adult CHF patients and in 2025 for those with CKD.
Commenting on the potential of the ReadyFlow Autoinjector, Michael Castagna, PharmD, CEO of MannKind, asserted, “This innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”
About FUROSCIX and Safety Considerations
FUROSCIX® (furosemide injection) is indicated for treating edema in both pediatric patients who weigh at least 43 kg and adults suffering from chronic heart failure or chronic kidney disease, including nephrotic syndrome. However, it is crucial to note potential contraindications. FUROSCIX should not be used in patients with anuria or those allergic to its components.
Adverse reactions may include site and skin reactions such as erythema, bruising, edema, and injection site pain. Comprehensive safety information and prescribing details are available on the official FUROSCIX website.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) is focused on transforming chronic disease management through innovative, patient-centered solutions. The company's portfolio addresses significant unmet medical needs, particularly in cardiometabolic and orphan lung diseases. MannKind aims to seamlessly integrate these therapies into the patients' daily lives.