Despite FDA approval, many generic drugs face multi-year delays due to patent litigation. Between 2023 and 2025, patent thickets extended monopolies by an average of 3.7 years, costing patients billions and creating widespread drug shortages.
Between 2023 and 2025, FDA-approved generic drugs faced average delays of 3.2 years before reaching patients due to patent litigation. This article breaks down how brand companies use patent thickets to block competition - and who pays the price.
The 30-month stay under the Hatch-Waxman Act delays generic drug approval by freezing FDA action during patent lawsuits. While meant to protect innovation, it's often used to extend monopolies, costing patients billions annually.