The US District Court for the District of New Jersey entered the order on 17 July 2014, preliminarily enjoining Actavis from marketing a generic version of Gralise prior to the court’s issuance of an opinion in the matter.

Gralise is a once-a-day treatment for pain from damaged nerves (neuropathic pain) that follows the healing of shingles caused by Herpes zoster infection. Depomed says it is not interchangeable with other gabapentin products.

A study published in the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2013 looking at four different generic versions of gabapentin concluded that gabapentin generics were therapeutically equivalent and could therefore be switched with confidence [1].

This latest court order indicates that the court expects to issue an opinion in ‘short order’. There are at least seven patents involved, which expire between September 2016 and February 2024. 

Depomed has been in patent infringement litigation against three separate filers of abbreviated new drug applications, including Actavis, seeking to market generic versions of Gralise 300 mg and 600 mg tablets. In April 2014, the company announced it had entered into settlement agreements with two of the defendants. The two settlements, involving Incepta Pharmaceuticals and Zydus Pharmaceuticals, permit both those companies to begin selling generic versions of Gralise on 1 January 2024, or earlier under certain circumstances.

These agreements are subject to review by the US Department of Justice and the Federal Trade Commission, and entry of an order dismissing earlier litigation by the US District Court for the District of New Jersey.

Reference
1.   Interchangeability of gabapentin generic formulations in The Netherlands: summary of a comparative bioavailability study. Generics and Biosimilars Initiative Journal (GaBI Journal) [www.gabi-journal.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 29]. Available from: www.gabi-journal.net/news/interchangeability-of-gabapentin-generic-formulations-in-the-netherlands-summary-of-a-comparative-bioavailability-study

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