Understanding Recent Trends in ANDA Submissions One Year Prior to Expiration of NCE Exclusivity (NCE-1)

In this report, we explore recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date.”

The NCE-1 date is often the first opportunity for a generic drug manufacturer to submit an ANDA referencing a branded drug with NCE exclusivity and is therefore critical for pursuing 180-day marketing exclusivity granted to a first-filed ANDA.

Whether to pursue an ANDA submission at an NCE-1 date is a complex decision for a generic drug manufacturer. Thus, examining trends in ANDA submissions at the NCE-1 date can provide useful insights into the changing dynamics in the generic drug landscape.