Tag: Hatch-Waxman Act

What Is an ANDA? Abbreviated New Drug Application Explained

16 Jun

Gregory Sterling 0

Learn what an ANDA is, how the FDA approves generic drugs, and why the Hatch-Waxman Act saves consumers billions. Understand bioequivalence, the Orange Book, and the difference between NDAs and ANDAs.

Patent Term Restoration: How Pharmaceutical Companies Legally Extend Drug Exclusivity

1 Feb

Gregory Sterling 15

Patent term restoration lets pharmaceutical companies recover lost patent time due to FDA approval delays. Learn how the Hatch-Waxman Act works, who qualifies, and why it's critical for drug development.

How Multiple Generic Drug Competitors Enter After the First Market Entrant

6 Jan

Gregory Sterling 14

After the first generic enters the market, prices crash as competitors rush in. But the real battle isn't about who gets approved first-it's about contracts, manufacturing, and brand strategies that determine who survives the price war.