Tag: Hatch-Waxman Act

Authorized generics let brand drugmakers launch their own low-cost versions during generic exclusivity, undercutting independent competitors and slowing price drops. This legal but controversial tactic distorts competition and keeps drug prices higher than they should be.

The Hatch-Waxman Act of 1984 balanced drug innovation and generic access. It created the ANDA pathway, patent term restoration, and Paragraph IV challenges. Today, generics make up 90% of prescriptions but only 18% of spending. Learn how this law works and its ongoing challenges.