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news.Horizon Pharma, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US patent application number 14/596,919 (U.S. publication number 2015-0126607), entitled "Diclofenac Topical Formulation" that covers Horizon's US approved product Pennsaid (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%).
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This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.
The US patent scheduled to issue from this application will expire in 2027. After issuance, Horizon plans to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the tenth U.S. patent to be listed in the Orange Book for Pennsaid 2%.
Pennsaid (diclofenac sodium topical solution) 2% w/w is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain of osteoarthritis (OA) of the knee(s).
Pennsaid 2% contains diclofenac sodium, an NSAID, and also includes dimethyl sulfoxide (DMSO), a powerful penetrating agent that helps ensure that diclofenac sodium is absorbed through the skin to the site of inflammation and pain.
Pennsaid 2% is an alternative to oral NSAID treatment, reducing systemic exposure to a fraction of that provided by the oral NSAID diclofenac.