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news.US-based specialty pharmaceutical company Depomed has announced it has entered into settlement agreements with two of the three defendants involved in the company's ongoing patent infringement litigation against filers of Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of its Gralise (gabapentin) 300mg and 600mg tablets.
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The settlements permit the defendants to begin selling generic versions of Gralise on 1 January 2024, or earlier under certain circumstances. The patent litigation continues against Actavis, the other Gralise ANDA filer.
The settlements involve Incepta Pharmaceuticals and Zydus Pharmaceuticals (USA), as well as their affiliated co-defendants.
The agreements are subject to review by the US Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the US District Court for the District of New Jersey.