modafinil.jpgRanbaxy Laboratories Ltd. agreed to settle patent litigation of the $500 million drug Provigil (modafinil) with Cephalon Inc. Under the agreement Ranbaxy can market its generic version of Provigil from October 2011, three years before the patent protection ends, on payment of royalty.

Cephalon and Ranbaxy also agreed to a series of business arrangements related to Modafinil including:

Cephalon will grant a non-exclusive royalty-bearing right to Ranbaxy to market and sell a generic version of Provigil in the United States, which 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. An earlier entry by Ranbaxy may take place based upon the entry of another generic version of Provigil.

Ranbaxy has agreed to grant to Cephalon a non-exclusive license to certain of its world-wide intellectual property rights related to modafinil in exchange for milestone payments.

Cephalon also has agreed to enter into certain arrangements with Ranbaxy related to Ranbaxy’s supply of the active pharmaceutical ingredient modafinil.

The two companies will now file for ‘a dismissal with prejudice’ with the District Court of New Jersey that will conclude all pending litigation between them regarding Provigil. These lawsuits claim infringement of Cephalon’s U.S. Pat. No. RE37,516, which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in Provigil. The patent expires in October 6, 2014, and may be extended by six months to April 6, 2015, upon submission of pediatric study data that is acceptable to the FDA.

This patent relates to the acetamide derivative modafinil, which is 2-(benzhydrylsulfinyl)acetamide and is also known as 2-[(diphenylmethyl)sulfinyl]acetamide. Modafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Modafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore doesn’t get enough restful sleep).

Modafinil has been described as presenting a “neuropsychopharmacological spectrum characterized by the presence of excitation with hyperactivity and of hypermotility; and by the absence of stereotypy (except in high doses) and of potentialization of the effects of apomorphine and amphetamine” (U.S. Pat. No. 4,177,290). Modafinil is thought to modulate the central postsynaptic alpha1-adrenergic receptor, without participation of the dopaminergic system. Modafinil has been successfully tested in humans for treatment of idiopathic hypersomnia and narcolepsy.

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