Barr Pharmaceuticals, Inc announced that its subsidiary Barr Laboratories, Inc. and Par Pharmaceutical Companies, Inc. have entered into a settlement agreement regarding their joint patent challenge with Valeant Pharmaceuticals North America related to Valeant's Diastat diazepam rectal gel products.
Under the terms of the settlement, Barr will have the right to launch generic versions of Diastat and Diastat AcuDial on or after September 1, 2010, or earlier in certain circumstances. Barr will record sales of the products and split the profits with Par. The settlement agreement reflects the terms previously agreed to in principle at a settlement conference in June 2007.
The patent challenge was initiated by Kali Laboratories, Inc. (since acquired by Par) and Pliva Inc. (since acquired by Barr). Under the terms of an earlier agreement between Pliva and Kali, Kali developed Diastat and Pliva assumed responsibility for the litigation and its associated costs.Diastat and Diastat AcuDial had combined sales of approximately $75 million for the twelve months ended August 2007, based on IMS sales data. The product is indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic medications (AEDS), who require intermittent use of diazepam to control bouts of increased seizure activity.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.