Recent Trends in ANDA Submissions One Year Prior to NCE Exclusivity Expirations

In this report, IPD explores 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, IPD examines trends in ANDA submissions at the NCE-1 date to provide useful insights into the changing dynamics in the generic drug landscape.