Cumberland Pharmaceuticals Inc.,a Tennessee-based specialty pharmaceutical company, has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a second patent relating to its new formulation of Acetadote (acetylcysteine) injection, which is used to treat acetaminophen overdose. The original composition of matter patent covered the Acetadote formulation and was issued in April 2012. The new patent includes claims regarding the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

This additional patent represents another significant milestone for Cumberland and its Acetadote brand.  A new formulation of Acetadote was FDA approved in 2011 and listed in the "Orange Book," the FDA's official register of approved pharmaceutical products. The original Acetadote patent was FDA "Orange Book" listed as well. The proprietary next generation formula does not contain Ethylene diamine tetraacetic acid (EDTA) or any other stabilization and chelating agents and is free of preservatives. This formulation was developed as part of a Phase IV commitment by Cumberland in response to a request by the FDA to evaluate the reduction of EDTA from the product's formulation. Following the approval of the next generation Acetadote product, the Company immediately ceased manufacture of the previous formulation.

"We believe that the new Acetadote patent represents an important development in our efforts to protect our intellectual property and defend our product," said A J Kazimi, chief executive officer of Cumberland Pharmaceuticals. "Intellectual property protection is a key objective for the company and we will continue to seek opportunities to expand our patent portfolio."

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.

Acetadote 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.