Tag: Hatch-Waxman Act

Learn how to accurately predict when generic drugs will enter the market after patent expiration, using real data from FDA filings, patent litigation, and pricing trends to protect revenue and plan strategy.

The Hatch-Waxman Amendments of 1984 created the modern generic drug system in the U.S., cutting costs by up to 90% and boosting generic market share to 90%. It balanced innovation incentives with patient access-and still shapes drug prices today.