When you pick up a generic version of your prescription, chances are the Hatch-Waxman Act, a 1984 U.S. law that created a path for generic drugs to enter the market without repeating full clinical trials. Also known as the Drug Price Competition and Patent Term Restoration Act, it’s the reason your $50 brand-name pill now costs $5.
This law didn’t just make drugs cheaper—it fixed a broken system. Before 1984, brand-name companies held patents that blocked generics for 17 years, even if the drug’s formula was simple. Meanwhile, generic makers couldn’t start testing until the patent expired, wasting years. The Hatch-Waxman Act changed that. It let generic companies file an ANDA, an Abbreviated New Drug Application that proves a generic is bioequivalent to the brand, without redoing expensive safety trials. At the same time, it gave brand-name companies up to five extra years of patent protection to make up for time lost during FDA review. This trade-off—faster generics for extended brand exclusivity—became the backbone of modern drug pricing.
But it’s not perfect. The law created loopholes. Some companies exploit patent extensions, file endless minor patents to delay generics (a tactic called "evergreening"), or settle lawsuits with generics to delay their entry. These delays keep prices high. Still, the Hatch-Waxman Act is why the U.S. saves $467 billion a year on drugs. It’s why your diabetes med, your blood pressure pill, or your antibiotic isn’t a luxury. And it’s why the FDA’s GDUFA, the Generic Drug User Fee Amendments that fund faster review of generic applications matters so much today.
What you’ll find below are real stories of how this law touches your life: how approval costs for generics can hit $375,000, why some drugs still cost too much even after generics arrive, how patent battles delay access, and how patients end up paying more because of paperwork delays—not science. These aren’t abstract policies. They’re the reason your pharmacy shelf looks the way it does—and why your wallet does too.
Authorized generics are brand-name drugs sold without the brand name, identical in every way. They're a strategic response to patent expiration, lowering prices while keeping quality - and confusing many patients.
