Horizon Pharma issues notice of allowance from USPTO for its anti-inflammatory drug

Horizon Pharma, a biopharmaceutical company focused identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, has issued a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 15/180,173, entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” that covers the U.S. approved medicine Vimovo (naproxen/esomeprazole) delayed release tablets.

The company said that 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 term of the U.S. patent scheduled to issue from this application will expire May 31, 2022. After issuance, Horizon and a subsidiary of Aralez Pharmaceuticals plan to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, Horizon said.

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.