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New Delhi, Dec. 23: Ranbaxy Laboratories Limited has entered into an agreement with Cephalon Inc to settle its pending patent infringement dispute over Provigil tablets in the US.
Provigil is used to treat excessive daytime sleepiness associated with narcolepsy. People suffering from narcolepsy may abruptly fall asleep at almost any time ? while talking, eating or walking.
According to the settlement, Cephalon will grant Ranbaxy a non-exclusive royalty-bearing right to market a generic version of Provigil in the US three years before Cephalons patent expires in 2014.
The company's licence will become effective in October 2011 in the absence of a pediatric extension for Provigil, which would delay the entry date by six months (to April 2012), it added.
Ranbaxy said an earlier entry might occur based on the entry of another generic version of Provigil.
The firms have also agreed to some business arrangements related to modafinil, the core ingredient used in the manufacture of Provigil.
Ranbaxy has agreed to give Cephalon an immediate non-exclusive licence to some of its worldwide intellectual property rights related to modafinil in exchange for milestone payments.
Cephalon has also agreed to enter into certain arrangements with Ranbaxy regarding the latters supply of the active pharmaceutical ingredient, modafinil. Financial terms of the agreement, however, were not disclosed.
The companies will soon file a dismissal with a US court that will conclude all pending litigation between the parties regarding Provigil.
These lawsuits claim infringement of patent granted in the US to Cephalon, which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in Provigil. The patent is scheduled to expire on October 6, 2014.
Earlier this month, Cephalon had entered into a similar agreement with Israeli generic drug manufacturer Teva for Provigil.
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