Tag: ANDA

180-day exclusivity Hatch-Waxman Act generic drug market patent challenge ANDA

180-Day Exclusivity in Generic Drug Market Entry: How Patent Challenges Shape Drug Prices

The 180-day exclusivity rule lets the first generic drug company to challenge a patent block competitors for six months. But delays, settlements, and loopholes often prevent patients from getting affordable meds-despite the law’s original intent.

January 15 2026