Natco receives USFDA tentative approval for armodafinil tablets

The Hyderabad Natco Pharma's marketing partner in US, Breckenridge Pharmaceutical Inc, has received a tentative approval from the US Food & Drug Administration (USFDA) for its generic Armodafinil tablets used for treating excessive daytime sleepiness associated with obstructive sleep apnoea, narcolepsy, and shift work disorder. Breckenridge has received the US drug regulator’s approval for Armodafinil 50 mg, 150 mg and 250 mg tablets.
 
Cephalon Inc, a wholly-owned subsidiary of Teva Pharmaceutical, currently sells armodafinil 50 mg, 150 mg, and 250 mg tablets under the brand name Nuvigil in the US market. Breckenridge had filed the abbreviated new drug application (ANDA) with a Paragraph IV certification to obtain approval to manufacture generic version of Nuvigil prior to expiration of the listed patents.
 
Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon. Cephalon has granted Natco and Breckenridge a license to market generic versions of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of Nuvigil, beginning 180 days after the initial launch of these strengths.
 
The market size of Nuvigil, a wakefulness promoting drug, in the US is around $457 million for twelve months ending August 2014, according to IMS Health.