Mannkind Announces Pediatric Approval Of FUROSCIX On‑Body Infusor And New IP Protection For ReadyFlow Autoinjector Under FDA Review

• FDA approves FUROSCIX® for use in pediatric patients weighing 43kg or above
• USPTO issues five patents for FUROSCIX ReadyFlow™ Autoinjector

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced two business updates—approval of the FUROSCIX® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA.

FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients

The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.

"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," said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.

Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector

The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind's intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA's Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.

The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.

FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds

MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.