Barr Labs and Par Pharmaceutical settle Diazepam patent case with Valeant

Barr Pharmaceuticals, Inc. today announced that its Barr Laboratories, Inc. subsidiary 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(R) diazepam rectal gel products.

Under the terms of the settlement, Barr will have the right to launch generic versions of DIASTAT(R) and DIASTAT(R) AcuDial(TM) 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(R) and DIASTAT(R) AcuDial(TM) 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.