FDA Updates Patent Database to Boost Generic Drug Competition
The FDA announced that it will add new information to its patent database, in a move the agency hopes will bring more sunlight into the ANDA approval process.
The FDA is adding new data to the Paragraph IV Patent Certifications List, including the status of 180-day exclusivity decisions for specific products, the dates of first approval, the marketing status, and the expiration dates of blocking patents.
“We are working hard to reduce approval times and to enhance the efficiency of certain aspects of the submission process for generic drug applicants,” said acting FDA Commissioner Ned Sharpless. The agency wants to offer “greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize their resources,” he said.