Cadila, Depomed Inc settle patent dispute

Ahmedabad-based pharma major Cadila Healthcare Limited (Zydus Cadila) and its subsidiary Zydus Pharmaceuticals (USA) Inc.,today announced that they have entered into an agreement with Depomed, Inc. to settle their ongoing patent infringement litigation related to neuropathic pain drug Gralise (gabapentin) 300 mg and 600 mg tablets.

The settlement permits Cadila and Zydus to begin selling generic versions of Gralise on January 1, 2024, or earlier under certain circumstances. Other terms of the settlement were not disclosed. Gralise is a neuropathic pain drug. It is estimated that Depomed posted a sales of around $36.2 million in 2013 for Gralise.

Depomed  is a specialty pharmaceutical company focused on developing products to treat pain and other central nervous system conditions. It currently four FDA-approved products, Gralise (gabapentin) tablets for the management of postherpetic neuralgia (PHN), Cambia for acute treatment of migraine attacks, Zipsor liquid filled capsules for relief of mild to moderate acute pain, and Lazanda nasal spray for the management of breakthrough pain in cancer patients.

“The agreement is 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,” the company statement here said.

Earlier, in December last year Cadila Healthcare and Zydus Pharmaceuticals (USA) Inc had settled a patent dispute with Warner Chilcott Company LLC related to Asacol delayed-release tablets.