Natco Pharma Ltd.

Natco Pharma’s marketing partner in the USA, Breckenridge Pharmaceutical, Inc. (BPI), has received a tentative approval from the United States Food & Drug Administration (USFDA) for Armodafinil 50mg, 150mg, and 250mg Tablets.

Breckenridge filed the Abbreviated New Drug Application (ANDA) with a Paragraph IV certification to obtain approval to engage in the commercial manufacture, use and sale of its generic to Nuvigil prior to expiration of the listed patents. Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, the terms of which are confidential. Cephalon has granted Natco and Breckenridge a license to market generic versions of the 50mg, 100 mg, 150mg, 200 mg and 250mg strengths of Nuvigil, beginning 180-days after the initial launch of these strengths.

Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under Brand name Nuvigil in the USA market. Nuvigil is a wakefulness promoting agent for oral administration. The market size of Nuvigil in the USA is approximately $457 million for twelve months ending August 2014, according to IMS Health.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.