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news.Horizon Pharma's affiliates have entered into a settlement and license agreement with Teligent, Inc. 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 Teligent the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Teligent’s Abbreviated New Drug Application (ANDA) beginning January 10, 2029 or earlier under certain circumstances.
The agreement follows the May 2, 2016, entry of a stipulation of dismissal without prejudice of all lawsuits filed by Horizon in the U.S. District Court for the District of New Jersey relating to the ANDA filed by Teligent 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.
About 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. 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.