Expanding Access to Low-Cost Generics Act of 2021

Expanding Access to Low-Cost Generics Act of 2021

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (4) no first applicant's application has been effectively approved on the date that all such conditions are met.