FDA Issues Final Rule Clarifying Patent Listing Requirements And Limiting Patent Holders To One 30-Month Stay Per ANDA

The FDA on June 12, 2003, released a final rule that (1) clarifies requirements for listing patents in the Orange Book and (2) limits the application of 30-month stays to one such stay per application for a generic drug. The final rule was published in the Federal Register on June 18, 2003. It becomes effective generally on August 18, 2003.