"This patent significantly expands the strength of the VIMOVO patent estate and extends patent protection out to 2031," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.
"In addition, this patent exhibits our commitment to innovation and ability to further strengthen the intellectual property protection of our portfolio of drugs. This is an important milestone in the commercial lifecycle for VIMOVO."
The USPTO issued U.S. patent number 8,945,621 on February 3, 2015. Horizon and POZEN plan to list the U.S. patent in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the eleventh U.S. patent to be listed in the Orange Book for 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.
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