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news.Horizon Pharma, a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced that its affiliates have entered into a settlement and license agreement with Perrigo Company and its subsidiary Paddock Laboratories, collectively (Perrigo), to resolve pending patent litigation involving Pennsaid (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%).
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Under the settlement and license agreement, Horizon has granted Perrigo the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Perrigo’s Abbreviated New Drug Application (ANDA), beginning January 10, 2029 or earlier under certain circumstances.
The agreement includes a stipulation by the parties requesting dismissal without prejudice of the lawsuits filed by Horizon in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Delaware relating to the ANDA filed by Perrigo with the U.S. Food and Drug Administration for a generic version of Pennsaid 2%.
Details of the settlement are confidential and the agreement is subject to submission to the Federal Trade Commission and the U.S. Department of Justice.
"This settlement further validates the innovation of Pennsaid 2% and the strength of our patent estate," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.
"We will continue to vigorously defend patent challenges in order to protect our innovation and ensure continued patient access."
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. The only topical NSAID offered with the convenience of a metered-dose pump, Pennsaid 2% is applied in two pumps, twice daily, to the site of OA knee pain.