Valeant Pharmaceuticals settles lawsuit on Diastat generic

Valeant Pharmaceuticals has announced the settling of a lawsuit with Kali Laboratories relating to patent infringement on Diastat (diazepam rectal gel) – an acute treatment for breakthrough epileptic seizures.

Diastat is the only at-home acute treatment for this condition currently approved by the US Food and Drug Administration (FDA).

This agreement follows an application by Kali with the FDA for an abbreviated new drug application for a generic form of Diastat in March 2005.

In July 2004, Xcel Pharmaceuticals filed a complaint against the firm for an infringement of its patent for the drug, while Xcel was acquired by Valeant in March the following year.

According to the settlement, Kali Pharmaceuticals will be permitted to introduce a generic formulation of Diastat and Diastat AcuDial, but not before September 2010. Financial details and other parts of the settlement have not been publicly disclosed.

“The settlement, which was reached at a conference held last week in the US District Court of New Jersey, requires the companies to finalize the agreement within 60 days,” Valeant notes.

Last month, Valeant reported that the launch of a share repurchase programme to re-buy common stock up to the value of $200 (100 million pounds) over a two-year period had been approved by its board of directors.