Actavis plc has entered into an agreement with Cephalon Inc to settle all outstanding patent litigation related to Actavis’ generic version of Nuvigil (armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg). 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.
For the 12 months ending February 28, 2014, Nuvigil had total US sales of approximately $437 million, according to IMS Health data.