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May 30, 2014
16:10 EDTACTActavis announces Nuvigil patent challenge settlement
Actavis announced that it has entered into an agreement with Cephalon to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil. Nuvigil is a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder or narcolepsy. Under the terms of the agreement, Cephalon will grant Actavis a license to market generic versions of 100 mg and 200 mg Nuvigil beginning on June 1, 2016, or earlier under certain circumstances. Cephalon will also grant Actavis a license to market generic versions of 50 mg, 150 mg and 250 mg Nuvigil beginning 180 days after the initial launch of generic versions of those dosage strengths. Other details of the settlement were not disclosed. Based on available information, Actavis believes it is a "first applicant" to file an ANDA for the generic versions of 100 mg and 200 mg Nuvigil and expects to be entitled to 180 days of generic market exclusivity.
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