Tentative Approval: What It Means for Generic Drugs and Patient Access

When the tentative approval, a conditional FDA status allowing generic drugs to be manufactured and sold once patents expire. Also known as pre-approval, it’s not full permission—but it’s the green light that keeps generics moving forward while patents are still in force. This isn’t just paperwork. It’s the reason you can buy cheap versions of expensive drugs today. Without tentative approval, many generics would sit on the shelf for years, even after they’re proven safe and effective.

Tentative approval is tightly tied to the Hatch-Waxman Act, the 1984 law that created the modern U.S. generic drug system by balancing patent rights with faster approval for copycats. It lets companies file an ANDA—Abbreviated New Drug Application—before a brand-name drug’s patent runs out. The FDA reviews the data, checks for bioequivalence, and if everything checks out, grants tentative approval. The drug can’t be sold yet, but the manufacturer can start production, pack inventory, and be ready to launch the second the patent expires. This cuts months, sometimes years, off the time it takes for generics to reach shelves.

It’s not perfect. Some brand-name companies stretch patents with minor tweaks—called evergreening—to delay generics. But tentative approval gives the FDA a tool to push back. If a generic passes all tests and the patent is found to be invalid or unenforceable, the FDA can quickly switch tentative to full approval. That’s how drugs like generic Lipitor and generic Plavix hit the market fast after their patents fell.

This system also affects who gets treated. For patients on long-term meds—like those for HIV, epilepsy, or COPD—waiting for a generic can mean choosing between rent and refills. Tentative approval helps bridge that gap. It’s why you’ll see multiple generic versions of the same drug appear almost overnight. And it’s why pharmacists now train to spot which ones are FDA-approved versus counterfeit. The whole chain, from manufacturer to pharmacy, depends on this one status: tentative approval.

Below, you’ll find real-world examples of how tentative approval shaped drug access—from the rise of generic antiretrovirals to the battle over patent cliffs and how companies fight to keep prices high. These aren’t theoretical debates. They’re the reason your prescription costs less today than it did five years ago.