Behind the 'First-Filer' Trend

Generic drug manufacturers are increasingly lining up to bring competing versions of brand-name products to the market. But that might be bad for consumers.

Being the first to launch a generic into the U.S. market grants a manufacturer 180 days of market exclusivity. However, competition among drug manufacturers doesn't mean patients will see lower drug costs. 

Generic drugmakers are increasingly applying for first-filer, or NCE-1 status, to make their own versions. Until 2003, just one drugmaker — the first to file— would receive 180 days of exclusivity. The law changed in 2003 allowing multiple generic drugmakers to obtain that status. In 2019, 14 brand-name drugs had multiple generic first-filers, up from seven in 2013 and zero in 2004. 

This growth in competing generic makers has led to increased litigation with brand-name drugmakers, defending their patents. Generic drugmakers often engage in patent battles so they can reach agreements with brand-name drugmakers that give them compensation to stay away from the market.

The settlements are often referred to as pay-for-delay or reverse payment deals.