Sept. 28, 2012
/PRNewswire/ -- Horizon Pharma, Inc. (NASDAQ: HZNP), announced today that it has received Notices of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application Serial No. 13/403,930 and U.S. Application Serial No. 13/403,923 both 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 Notices of Allowance conclude the substantive examination of these patent applications and will result in the issuance of U.S. patents after administrative processes are completed. The patents scheduled to issue from these applications will expire in 2028 for the U.S. patents. After issuance, Horizon plans to list the U.S. patents in the FDA's
Approved Drug Products with Therapeutic Equivalence Evaluations
, or Orange Book.
"These recent Notices of Allowance in the U.S. represent an important expansion of the patent estate for DUEXIS," said
Timothy P. Walbert
, chairman, president and chief executive officer, Horizon Pharma. "Horizon's goal is to protect the commercial potential of DUEXIS to 2028 and these Notices of Allowance are a significant step toward achieving this goal."
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 6 months. For more information, please visit
Important Safety Information About DUEXIS
DUEXIS is not right for everyone. People who have had asthma, hives, or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2‐receptor antagonists) should not take DUEXIS.
Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.