The United States Patent and Trademark Office (USPTO) has issued a notice of allowance to Horizon Pharma, Inc. for its US Patent Application Serial No. 13/620,150 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.
"This additional Notice of Allowance for Duexis, our fourth in the US, continues to validate the strength of our intellectual property for Duexis," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "Horizon will continue to vigorously expand and protect the innovation and intellectual property of Duexis, with protection currently out to 2028."
The Notice of Allowance concludes the substantive examination of this US patent application and will result in the issuance of the 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. Horizon has now been granted four patents covering Duexis in the US since October 2011.
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 commercialising Duexis and Rayos/Lodotra, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases.