Tag: Hatch-Waxman Act
14May
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.
17Feb
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.