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news.Barr Laboratories and Par Pharmaceutical Companies have settled their joint patent challenge with Valeant Pharmaceuticals North America, related to Valeant's diastat diazepam rectal gel products.
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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 patent challenge was initiated by Kali Laboratories, (since acquired by Par) and Pliva (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.
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.