Cumberland Receives Acetadote® Patent Notice of Allowance

Cumberland Pharmaceuticals Inc.

today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office relating to its new formulation of Acetadote® (acetylcysteine) Injection, which is used to treat acetaminophen poisoning. The new formulation was FDA approved in 2011 and listed in the "Orange Book," the FDA's official register of approved pharmaceutical products. Once issued, the patent will expire in August 2025. This composition of matter patent represents another significant milestone for Cumberland and its Acetadote brand. The proprietary next generation formula does not contain Ethylene diamine tetracetic acid (EDTA) or any other stabilization and chelating agents and is free of preservatives. The formulation also has a longer shelf life of 30 months compared to 24 for the prior formulation. This new formulation was developed as part of a Phase IV commitment by Cumberland in response to a request by the FDA to remove EDTA. Following the approval of the next generation Acetadote product, the Company immediately ceased manufacture of the previous formulation.