Nuvigil is a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) or narcolepsy.
As part of the deal, Cephalon will grant Actavis a license to market generic versions of 100mg and 200mg Nuvigil starting 01 June 2016, or earlier under certain circumstances.
Actavis will also received a license to market generic versions of 50mg, 150mg and 250mg Nuvigil beginning 180 days after the initial launch of generic versions of those dosage strengths.
Based on available information, the Irish firm believes that it is a first applicant to file an abbreviated new drug application (ANDA) for the generic versions of 100mg and 200mg Nuvigil and expects to be entitled to 180 days of generic market exclusivity.
The company is focused in developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.