Tag: generic drugs

Explore how generic drugs move from FDA ANDA approval to retail shelves. Learn about bioequivalence, manufacturing scales, PBM negotiations, and the timeline from application to patient access.

Bioequivalence testing proves generic drugs deliver the same active ingredient at the same rate and extent as brand-name versions. This science-based standard ensures safety, effectiveness, and massive cost savings - with over 90% of U.S. prescriptions filled with generics.

Despite FDA approval, generic drugs in the U.S. face average delays of 3.2 years before reaching patients due to patent litigation and complex regulatory tactics. Real-world examples from 2023-2025 show how brand companies use patent thickets to block competition, driving up costs and limiting access.