Lupin Pharmaceuticals, a US subsidiary of Indian-based Lupin Limited, said that final approval is expected upon the expiration of the first abbreviated new drug application filer’s 180-day marketing exclusivity in February 2007.
Lupin’s sertraline tablets will be the AB-rated generic equivalent of Zoloft, which had annual sales of approximately $3.1 billion for the twelve months ended July 2006, based on IMS sales data.