BioCentury
ARTICLE | Company News

Lupin, Pozen autoimmune news

August 24, 2015 7:00 AM UTC

Lupin filed three inter partes review (IPR) petitions with the U.S. Patent and Trademark Office challenging patents from Pozen covering Vimovo naproxen/esomeprazole. Lupin alleged that several claims from U.S. Patent Nos. 8,852,636; 8,858,996; and 8,865,190 are unpatentable on the grounds of obviousness. The ‘636 and ‘996 patents cover Vimovo’s composition and method of use and expire in 2022. There are 11 Orange Book-listed patents covering Vimovo. One patent expired earlier this year, and the last expires in 2031. The ‘190 patent covers Vimovo’s manufacturing process and method of use and will expire in 2022. It is not listed in FDA’s Orange Book.

Vimovo is a fixed-dose combination of 20 mg naproxen plus 500 mg esomeprazole, a proton pump inhibitor (PPI). It is approved in the U.S. to treat signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis; and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers ...