Depomed settlements with two Gralise ANDA filers

US specialty drugmaker Depomed (Nasdaq: DEPO) has entered into settlement agreements with two of the three defendants involved in Depomed's ongoing patent infringement litigation against filers of Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of Depomed's Gralise (gabapentin) 300mg and 600mg tablets.

The settlements allow the defendants to begin selling generic versions of Gralise on January 1, 2024, or earlier under certain circumstances. The patent litigation continues against Actavis, the other Gralise ANDA filer, said Depomed, which posted sales of $36.2 million in 2013 for Gralise, an oral once-daily treatment for patients with post-herpetic neuralgia, also known as after-shingles pain.

The settlements involve Incepta Pharmaceuticals and Zydus Pharmaceuticals (USA), a unit of India’s Cadila Healthcare, 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.