Tag: Paragraph IV certification

Landmark court decisions like Amgen v. Sanofi and Allergan v. Teva have reshaped how generic drugs enter the market, directly affecting drug prices. These cases define the legal boundaries between innovation and affordability.

FDA's 180-day exclusivity gives the first generic drug applicant a legal monopoly to delay competition-sometimes for years. Learn how it works, who benefits, and why reform is on the horizon.

Patent disputes in the generic drug market are delaying affordable medications for millions. Learn how the Hatch-Waxman Act, Orange Book listings, and serial litigation are driving up drug costs-and what’s being done to fix it.