Ensuring Timely Access to Generics Act of 2025

This bill amends FDA review procedures to prevent delays in generic drug approvals. It requires drug companies challenging generic applications to submit a petition to the FDA within 180 days of knowing the relevant information, rather than immediately filing lawsuits. The FDA must issue a final decision on such petitions within 151 days, and courts will automatically dismiss lawsuits that skip this step or miss the 180-day deadline. These changes directly affect pharmaceutical manufacturers seeking to challenge generic drug approvals or delay their market entry.