United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Horizon Pharma for U.S. patent application number 14/954,082, entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” that covers the U.S. approved medicine VIMOVO (naproxen/esomeprazole) delayed release tablets.
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire May 31, 2022. After issuance, Horizon and Aralez Pharmaceuticals Inc. plan to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
Horizon Pharma About VIMOVO
VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond six months. VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.