Hatch-Waxman Act: How Generic Drugs Got Their Footing in the U.S. Market

When you pick up a generic version of your prescription, you’re benefiting from a law passed in 1984 called the Hatch-Waxman Act, a U.S. law that created a path for generic drugs to be approved faster while protecting brand-name drug patents. Also known as the Drug Price Competition and Patent Term Restoration Act, it’s the reason you can buy metformin, lisinopril, or ibuprofen for a fraction of what the brand name costs. Before this law, generic makers had to repeat expensive clinical trials just to prove a drug worked—same active ingredient, same dosage, same effect—but the brand company held exclusive rights for years. Hatch-Waxman changed that by letting generics prove they’re bioequivalent, not brand new.

This law didn’t just help patients save money—it reshaped the entire pharmaceutical ecosystem. It gave brand-name companies a way to extend their patent life by up to five years if they spent time getting FDA approval, which encouraged innovation. At the same time, it gave generic manufacturers a clear, faster route to market by letting them file an Abbreviated New Drug Application, or ANDA. That’s why today, over 90% of prescriptions in the U.S. are filled with generics. The FDA, the federal agency that regulates drugs and ensures they’re safe and effective now reviews thousands of ANDAs each year, and the generic drug, a lower-cost version of a brand-name medication with the same active ingredient, strength, and dosage form market is worth over $100 billion annually.

But it’s not perfect. Some brand-name companies have used legal loopholes—like filing multiple patents or paying generics to delay entry—to keep prices high. That’s why you’ll see posts here about how to spot generic substitution in workers’ compensation, how to talk to seniors about switching meds, and how discount cards like GoodRx help stretch savings even further. You’ll also find real-world advice on managing medications like metformin, insulin, or SGLT2 inhibitors, all of which became more affordable thanks to this law. Whether you’re paying out-of-pocket, dealing with insurance, or helping a family member navigate prescriptions, the Hatch-Waxman Act is the invisible force behind most of your savings.

Below, you’ll find practical guides on how to use generic drugs safely, how to reduce copays, how to store them during travel, and how to read FDA alerts when something changes. This isn’t just about law—it’s about access. And that’s what makes the Hatch-Waxman Act one of the most important health policies you’ve never heard of.