Natco's US partner gets FDA nod for wakefulness tablets

Market size of the drug in the US is about $457 million for twelve months ending August 2014

Natco Pharma's marketing partner in US, Breckenridge Pharmaceutical Inc, has received a tentative approval from the US health regulator for its generic Armodafinil tablets used for improving wakefulness in adults.

Breckenridge Pharmaceutical Inc has received tentative approval from the United States Food and Drug Administration (US FDA) for Armodafinil tablets in the strengths of 50mg, 150mg, and 250mg, Natco Pharma said in a filing to the BSE.

Breckenridge had filed its abbreviated new drug application (ANDA) with a Paragraph IV certification to obtain approval to manufacture, use and sale of its generic Nuvigil tablets prior to expiry of the listed patents, it added.

"Currently Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg tablets under the brand name Nuvigil in the US market," Natco Pharma said.

Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, the company added but did not give details saying the terms are confidential.

"Cephalon has granted Natco and Breckenridge a license to market generic versions of the 50mg, 100mg, 150mg, 200mg and 250mg strengths of Nuvigil, beginning 180 days after the initial launch of these strengths," Natco Pharma said.

According to IMS Health, the market size of Nuvigil in the US is around $457 million for twelve months ending August 2014, it added.

Shares of Natco Pharma were trading 4.64 per cent up at Rs 1,320.20 per scrip during afternoon trade on the BSE.