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

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

Taking a generic drug is not like buying a store-brand soap. With the soap you might notice a difference. It may smell a bit different. Maybe you need to use more of it per load of dishes or laundry than the brand-name product.

But the same isn’t true with generic drugs. Generic drugs are like brand name drugs.

When drug companies make a brand-name drug, they get a patent for that drug. A patent protects the drug company from other drug companies making and selling the same drug until the patent expires.

Once the patent on a brand-name drug expires, other drug companies are able to make a generic version. After getting approval from the U.S. Food and Drug Administration (FDA), the generic drug is made and sold under the active ingredient’s name.

So companies can get permission to copy another company’s product? Patents expire so that good ideas can be shared with more people. And it encourages inventors to come up with even better ideas.

Compare the common myths about generic drugs and discover the myth-busting facts.

Myths Facts
Generics are not as safe as brand-name drugs. Generics use the same ingredients, work the same in the body and have the same risk-benefit profile.
Brand-name drugs are made in modern manufacturing facilities, and generics are often made in sub-standard facilities. Use of sub-standard facilities is not permitted by the FDA.
Generics are not as potent as brand-name drugs.  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 as the original brand drug.


How does the FDA allow a company to make and sell a generic drug:

  1. There must be an FDA-approved brand-name drug that the generic is meant to copy. The generic must have the same ingredients at the same strength as the first drug. It must come in the same form. Tablets, patches and liquids are examples of forms. It must be taken the same way — swallowed as a pill or given as an injection, for example.
  2. The drug company must show that the generic drug is "bioequivalent" to the brand-name drug (See below). Basically, your body should not be able to tell the difference between a brand-name drug and its generic.
  3. The generic drug's labeling must be the same as that of the first brand-name drug.
  4. The drug company must prove the generic drug's chemistry, how it’s made and how the company controls quality. Each step of the process must be spelled out for FDA review.
  5. The drug company must show the FDA that the ingredients and the finished product meet standards for purity.
  6. The drug company must show that its generic drug is stable (doesn’t change over time or in normal conditions) before it can be sold. Once it’s on sale, the company must watch to be sure the drug stays stable. The company must show that the packaging materials won't change the drug.
  7. The drug company must give a full description of the facilities it uses to manufacture, process, test, package, label and control the drug. It must show that it follows federal rules about current good manufacturing practices. The company must also agree to FDA inspection of the manufacturing facility.
  8. Before the FDA approves a generic drug, it usually inspects the manufacturing site to make sure the company is able to fulfill its promises and keep the supply of the generic steady.
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 trademarked name by the drug company Sold under the active ingredient(s) name(s)


 Why should I care about bioequivalence?

Generics don’t have to repeat the long clinical trials that have already been used to create the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients.

Since the safety and usefulness of the brand-name product has already been proven in research and during many years of patient use, the FDA says that it is not necessary or ethical to repeat testing in human subjects for each generic drug that a company wants to sell.

Instead, companies that want to make generics must show that their product is bioequivalent to the brand drug. That means it is made in the same way with the same ingredients, and it acts the same in the body.

The rules for approving generic copies of drug products were established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same tests as generics when their manufacturers change them.