What Is a Generic Medication?

If you’ve ever taken a prescription to a pharmacy in the United States, odds are you’ve left with a generic medication. That’s because off-brand drugs are used to fill 9 out of 10 prescriptions, reports the U.S. Food and Drug Administration (FDA).

But have you ever wondered what exactly you’re getting with a generic drug? Let’s take a closer look with pharmacist Marcia Wyman, PharmD, BCPS.

How are generic medications made?

When a pharmaceutical company develops a new medicine, the FDA allows it to be the exclusive maker and seller of that drug for a set time under a patent agreement. That allows the company to recoup the dollars spent developing and marketing the drug without competition.

Once the patent agreement expires, other drug companies can bring a generic version of the medication to the market.

Generic drugs must be approved by the FDA before they can be made available to patients in the U.S., says Dr. Wyman. The manufacturer must prove that its version is the same as the brand-name drug in several ways, including:

• Active ingredient(s)
• Strength or potency (such as milligrams or the percentage of a drug in the medication)
• Dosage form (such as a capsule or tablet)
• What it’s used for
• How it’s taken or applied (such as orally or topical)
• How it’s absorbed in the body
• How long it lasts on the shelf

The goal is to establish that a generic medication is the “bioequivalent” of a brand-name drug. By doing this, the generic manufacturer does not have to repeat the costly and time-consuming clinical trials done by the brand-name drug maker to show the medication is safe and effective.

Now a generic drug can be different from its brand-name counterpart in ways that do not affect how it works, explains Dr. Wyman. For example, a tablet can be a different color or shape. Generic drugs also may contain different inactive ingredients such as flavorings and fillers.

Why do generic medications cost less?

Companies can charge less for generic medications because they do not have to spend millions of dollars on research, clinical trials and marketing like the original maker of any brand-name drug.

Generics also create competition in the marketplace, which can drive down prices even further, notes Dr. Wyman.

Are generic drugs lower quality?

The lower price tag on a generic medication does not mean lower quality, emphasizes Dr. Wyman.

Manufacturers of generics must demonstrate to the FDA that the ingredients in their drugs are safe and that the drugs are made using current good manufacturing practices (CGMPs). Once a generic drug is approved and sold, the FDA continues to monitor it as it also does with brand-name drugs.

Makers of generic drugs are also required to tell the FDA if any serious side effects or dangerous reactions to its drugs are reported by consumers.

How to choose between generic and brand-name drugs

There are generic versions of many drugs available today. So are they the right choice for you? A lot can go into making that decision, says Dr. Wyman.

Most states have laws allowing pharmacists to substitute a less expensive generic for a brand-name drug unless:

• The doctor specifies to “dispense as written”
• It’s a drug considered to have what’s called a “narrow therapeutic window” in which a change from the brand-name product could potentially affect efficacy or increase side effects due to differences in absorption between the brand-name and generic versions

Many hospitals and healthcare systems also have processes in place to evaluate and decide which medicines to offer — meaning they might not make certain drugs available.

Know that you can always request brand-name medications at a pharmacy if that’s your preference, says Dr. Wyman. However, be aware that many insurance companies often provide better coverage for generics because of their lower cost.

With so many FDA-approved medications out there, Dr. Wyman recommends getting your prescriptions filled at one pharmacy and developing a relationship with that pharmacist. Dealing with a familiar face comes with benefits, after all.

“That way, you can feel comfortable asking questions and having conversations with the pharmacist,” explains Dr. Wyman. “They are going to be able to give you some good advice.”