US court preliminary order to prevent Actavis launch of generic Gralise

18 July 2014
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Judge Joel Pisano of the US District Court for the District of New Jersey has entered an order preliminarily enjoining generics major Actavis (NYSE: ACT) from marketing a generic version of US specialty drugmaker Depomed’s (Nasdaq: DEPO) Gralise (gabapentin) prior to the court's issuance of an opinion in the matter.

The order indicates the court expects to issue an opinion in short order. The patents asserted in the law suits expire between September 2016 and February 2024 and include US Patent Nos 6,635,280; 6,488,962; 7,438,927; 7,731,989; 8,192,756; 8,252,332; and 8,333,992. Gralise is a once-daily treatment approved for the management of post-herpetic neuralgia (or shingles), which posted sales of $36.2 million in 2013.

On May 20, a bench trial was completed before Judge Pisano in the patent litigation between Depomed and defendants Actavis Elizabeth LLC and Actavis related to an Abbreviated New Drug Application filed by Actavis seeking to market generic versions of 300mg and 600mg dosage strengths of Gralise prior to the expiration of the patents asserted in the litigation.

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