Tag: Hatch-Waxman Act

What is an ANDA: Abbreviated New Drug Application Explained
  • 16
  • Aug

What is an ANDA: Abbreviated New Drug Application Explained

Learn what an ANDA is and how it enables generic drugs to reach the market. We explain the FDA approval process, bioequivalence requirements, and the economic impact on prescription costs.

Predicting Generic Entry: Forecasting When Your Drug Gets Generics
  • 3
  • Jan

Predicting Generic Entry: Forecasting When Your Drug Gets Generics

Predicting when a drug will face generic competition isn't about patent dates-it's about FDA approvals, lawsuits, and strategic delays. Learn how to forecast generic entry with real data and industry insights.

First Generic Approval: Why It Matters and What It Means for Drug Prices and Patient Access
  • 10
  • Nov

First Generic Approval: Why It Matters and What It Means for Drug Prices and Patient Access

First generic approval gives a company 180 days of exclusive rights to sell the first generic version of a brand-name drug, driving down prices and increasing access. Learn how it works, why it matters, and who benefits.