Bill > S3092

This bill, the Expanding Access to Low-Cost Generics Act of 2019, amends the Federal Food, Drug, and Cosmetic Act to modify the 180-day exclusivity period for generic drug applications. The key change is that the 180-day exclusivity period will now be effective on the date of the first commercial marketing of the drug by any first applicant, rather than being triggered by a court decision finding the relevant patents to be invalid or not infringed. The bill also includes additional requirements for the first applicant, such as not staying the court action and not agreeing to be bound by a judgment as to another applicant. These amendments apply only to generic drug applications filed after the date of enactment of this Act.