7 Jan 2026
180-day exclusivity under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly to incentivize patent challenges. But delays in market entry can block competition for years, keeping prices high for patients.
21 Dec 2025
The 180-day exclusivity rule was meant to reward generic drug companies that challenge patents. But brand-name companies can launch their own versions - authorized generics - during that time, undercutting the reward and slowing real competition.
