The United States Patent and Trademark Office (USPTO) has issued Notice of Allowance to Cumberland Pharmaceuticals' 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.

“We are very pleased with the patent office's decision and appreciate their thoughtful deliberation and consideration of our application,” said A J Kazimi, CEO of Cumberland Pharmaceuticals. “Protecting our intellectual property is paramount for our Company and we are excited about the prospects for this potentially life-saving product.”

Acetadote is used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain relief and fever-reducing products. Acetaminophen continues to be the leading cause of poisonings reported by hospital emergency rooms in the United States, and Acetadote has become a standard of care for treating this potentially life-threatening condition.

Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers.

Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. It should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.

Cumberland Pharmaceuticals Inc. is focused on the acquisition, development and commercialization of branded prescription products.