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Horizon receives notice of allowance for US patent to Vimovo delayed release tablets
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Dublin, Ireland
Saturday, August 22, 2015, 14:00 Hrs  [IST]

Horizon Pharma plc, a biopharmaceutical company announced the issuance of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/515,627 (US publication number 2015-0125524), entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” that covers the US 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 US patent after administrative processes are completed. The US patent scheduled to issue from this application will expire in 2022. After issuance, Horizon and POZEN Inc. plan to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the twelfth US patent to be listed in the Orange Book for Vimovo.

Vimovo 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.

The most common side effects of Vimovo include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain and nausea.



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