Hatch-Waxman Act: How It Shapes Generic Drugs and Drug Prices

When you pick up a generic version of a brand-name drug, you’re seeing the result of the Hatch-Waxman Act, a 1984 U.S. law that created the modern pathway for generic drug approval. Also known as the Drug Price Competition and Patent Term Restoration Act, it’s the reason you can buy cheaper versions of pills like lisinopril, metformin, or sertraline instead of paying hundreds for the brand name.

This law didn’t just make drugs cheaper—it fixed a broken system. Before 1984, companies spent years and millions developing generics, but faced endless legal battles just to prove they worked the same as the original. The Hatch-Waxman Act let generic makers file an Abbreviated New Drug Application (ANDA) with the FDA, skipping costly clinical trials if they could show their product matched the brand in strength, safety, and how the body absorbs it. That’s why today, nearly 9 in 10 prescriptions in the U.S. are filled with generics. But it wasn’t just about generics. The law also gave brand-name drugmakers an extra five years of patent protection to make up for time lost during FDA review. That trade-off—more time for innovators, faster access for patients—is what made the law stick.

It’s not perfect. Some companies abuse the system by making tiny changes to a drug just to extend patents, a tactic called "evergreening." Others delay generics by paying them to stay off the market—a practice courts are now cracking down on. Still, the Hatch-Waxman Act, a 1984 U.S. law that created the modern pathway for generic drug approval. Also known as the Drug Price Competition and Patent Term Restoration Act, it’s the reason you can buy cheaper versions of pills like lisinopril, metformin, or sertraline instead of paying hundreds for the brand name. remains the backbone of how drugs get to you. It connects FDA approval, the process by which the U.S. Food and Drug Administration evaluates whether a drug is safe and effective for public use with drug patents, legal protections that give manufacturers exclusive rights to sell a drug for a set period, and forces both sides to play by rules that keep prices down without killing innovation.

What you’ll find in the posts below aren’t direct discussions of the Hatch-Waxman Act—but they’re all shaped by it. The cost of your birth control, the availability of your blood pressure med, even whether your doctor can switch you to a generic without asking—those decisions trace back to this law. You’ll see how pharmacists prevent errors with generics, how people compare branded and generic versions of Seroquel or Accutane, and why some drugs still cost too much despite being off-patent. This isn’t just policy. It’s your medicine cabinet.