Leo’s Law extends certain exclusivity periods for orphan drugs affected by the COVID-19 pandemic.
Leo’s Law extends certain exclusivity periods for orphan drugs impacted by the COVID-19 pandemic. Specifically, it extends by 180 days the 12-year period for marketing exclusivity, the 5-year period for data exclusivity, and other related periods for orphan drugs. This extension applies to drugs for rare diseases or conditions that meet the criteria of a "covered orphan drug." The law also extends the corresponding patent-related approval delay periods for certain orphan drugs.
The filed bill text is too short for analysis.