Horizon Pharma, Inc. has received a notice of allowance (NOA) from the United States Patent and Trademark Office (USPTO) for US Patent Application Serial No. 13/620141 entitled "Stable Compositions of Famotidine and Ibuprofen" with claims that cover Duexis (ibuprofen and famotidine) tablets. Duexis is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers.

The notice of allowance concludes the substantive examination of this US 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 2028. After issuance, Horizon plans to list the US patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

"This is the fifth Notice of Allowance in the US for Duexis and represents yet another important expansion of its patent estate," said Timothy P Walbert, chairman, president and chief executive officer, Horizon Pharma. "Horizon's goal is to protect the innovation and commercial potential of Duexis and this Notice of Allowance, along with the previous patents issued, further strengthens our position."

Duexis, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond six months.

Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing Duexis and Rayos/Lodotra, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases.