How Does a Drug Become a Generic: Facts vs. Myths

How Does a Drug Become a Generic: Facts vs. Myths

How Does a Drug Become a Generic: Facts vs. Myths

Lee esto en EspañolTaking a generic drug is not like buying a store-brand soap. With soap, you might notice a difference. It may smell different. You may need to use more than the brand-name product. That is not true with generic drugs. 

When companies make a brand-name drug, they get a patent. A patent stops other drug companies from making and selling the same drug before the patent runs out. When the patent on a brand-name drug expires, other drug companies can make a generic version. Generic versions can be equivalents or authorized generics, which are exact copies of the original brand name drug, or generic alternatives. Generic alternative drugs treat the same condition but do not have the same ingredients.

After getting approval from the U.S. Food and Drug Administration (FDA), leaving site icon the generic drug is made and sold under the active ingredient’s name.

Common Myths and Facts About Generic Drugs
Myths Facts
Generics are not as safe as brand-name drugs. Generic equivalents use the same ingredients. They work the same. They have the same risk-benefit profile.
Generics are not as strong. Generic drugs have the same quality, strength, purity and stability.
Generics take longer to act in the body. The generic drug delivers the same amount of active ingredient in the same time span.
Brand-name drugs are made in modern manufacturing facilities, and generics are not. Use of sub-standard facilities is not permitted by the FDA.
Brand-name drug  Generic drug
FDA Approved FDA Approved
Marketed and developed by one drug company Made and sold by more than one company 
Sold under the trademark Sold under the trademark (authorized generics)

What Is Bioequivalence?

Generics don’t have to repeat the long clinical studies used to make the brand-name drug. The safety and value of the brand-name product has already been proven with research and many years of patient use.

Instead, companies that want to make a generic must show the FDA that it is a “bioequivalent” to the brand drug. That means:

  • It is made in the same way.
  • It is made with the same ingredients.
  • It acts the same in the body.
How It Works

The FDA considers several factors before it allows a company to make and sell a generic equivalent drug.

  1. There must be an FDA-approved brand-name drug the generic can copy.
  2. The generic must have the same ingredients at the same strength.
  3. It must come in the same form, like a tablet or liquid. It must be taken the same way — swallowed or given as a shot.
  4. The drug company must show that the generic is bioequivalent to the brand-name.
  5. The generic's labeling must be the same.
  6. The drug company must prove the generic's chemistry, show how it’s made and uphold quality controls.
  7. Ingredients and the finished product must meet purity standards.
  8. The generic must be stable. It can’t change over time or in normal conditions.
  9. The company must follow federal rules for good manufacturing. It must allow FDA inspections.
  10. Before the FDA approves a generic drug, it often checks the manufacturing site to make sure the company can meet its promises and produce a steady supply.

Now that you know the care and safety that goes into making generic drugs, you can take yours with peace of mind.

Sources: Generic Drug Facts, leaving site icon U.S. Food and Drug Administration (FDA), 2021; What Is the Approval Process for Generic Drugs?, leaving site icon FDA, 2017, Generic Competition and Drug Prices, FDA, 2023 leaving site icon

Originally published 5/11/2016; Revised 2021, 2023