FDA Expands Paragraph IV Patent List To Help Boost Generic Competition

FDA has expanded its patent certification list to include additional data that can help subsequent generic drug applicants determine when their products can be approved and marketed, the agency announced Tuesday (June 18). The list now includes information on the status of 180-day exclusivity decisions for drugs, dates of first approval, marketing status and expiration dates of blocking patents -- information the agency says will help boost competition and drive down prices for consumers. The generic drug application process requires...