Tag: Hatch-Waxman Act
History of Generic Drugs in the United States: From 1820 to Today
Explore the history of generic drugs in the US, from the 1820 USP to the Hatch-Waxman Act. Learn how regulation evolved after tragedies like Elixir Sulfanilamide to create today's safe, affordable generic market.
How the FDA Ensures Generic Drugs Work the Same as Brand Names
Discover how the FDA ensures generic drugs are as effective as brand names through bioequivalence testing and strict manufacturing standards. Learn about the ANDA process, Hatch-Waxman Act, and why generics save billions.
Patent Term Extension (PTE): How Drug Companies Extend Patent Life Explained
Learn how Patent Term Extension (PTE) allows drug companies to recoup time lost during FDA review. We explain the Hatch-Waxman Act rules, eligibility criteria, calculation formulas, and ongoing debates about market exclusivity.
Future Role of Authorized Generics: Market Outlook
Authorized generics let brand drug makers stay competitive after patents expire by selling their own drugs under generic labels. With new FDA policies and rising generic market growth, their role is shifting from delay tactic to strategic pricing tool.