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Horizon Pharma Announces Receipt of Additional U.S. Patent Allowance for DUEXIS(R)
By: Marketwired .
Feb. 5, 2013 07:30 AM
DEERFIELD, IL -- (Marketwire) -- 02/05/13 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. 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 U.S., 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 U.S. patent application and will result in the issuance of the U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire in 2028. After issuance, Horizon plans to list the U.S. 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 U.S. since October 2011.
Important Safety Information About DUEXIS
Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.
NSAID-containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.
Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems, or liver problems, or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.
Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing or if you develop swelling of your face or throat.
The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain and headache.
Please see Medication Guide and full Prescribing Information, available at www.DUEXIS.com.
About Horizon Pharma
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