New Jersey court blocks Actavis’s generic Gralise

The US District Court for the District of New Jersey has ruled that Actavis may not launch a generic version of California-based Depomed’s Gralise (gabapentin), it has been announced.

Actavis had filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Gralise.

The court found that Actavis infringed seven of the patents that cover Gralise, and upheld the patents’ validity. Depomed has nine patents listed in the Orange Book that are due to expire between 2016 and 2024.

Gralise is a tablet used to treat postherpetic neuralgia, ie, pain after shingles. In 2013, it generated sales of $36 million.

Jim Schoeneck, Depomed’s president and chief executive officer, said: “We are pleased with this decision, as it confirms the innovation of Gralise and the strength of our patents.  This ruling provides for nearly 10 years of additional market exclusivity.

“We look forward to providing Gralise to postherpetic neuralgia patients and their physicians well into the next decade.”

In April, Depomed settled all litigation with pharmaceutical companies Incepta and Zydus, which were also seeking to launch generic gabapentin tablets before expiration of the Gralise patents.