Discussing Brand Versus Generic Medications

Seema Ledan, PharmD


US Pharmacist. 2020;45(6):25-30. 

In This Article

Discussion Points

Due to misconceptions and lack of understanding of the difference between brand and generic products, educating patients about the facts is vital. Outlined in the next few paragraphs are concepts of discussion that may be important to our patients.

What is the Difference Between Active and Inactive Ingredients?

An active ingredient is the component of the drug that produces the pharmacologic effect on the body. Active ingredients may undergo chemical changes as the product was manufactured and be present in a modified form for it to provide its effect.[6] An example of this would be an extended-release formulation of a medication. An inactive ingredient is a component of the drug that does not affect the therapeutic action of the medication on the body. Inactive ingredients are added to a drug product to help with binding, flavoring, coloring, preserving, or drug transport. Select examples of inactive ingredients are alcohol, gelatin, galactose, lactose, and saccharin.

To gain FDA approval, a generic medication must contain the same active ingredient as the originator medication (i.e., brand-name product). Although the inactive ingredients may be different, the FDA regularly conducts extensive reviews of the generic products to ensure they meet standards. The FDA understands that there may be variability in each batch made, but the amount of variability is limited. This variability can occur between branded medications and generics, but it also can take place between brands as well, due to slight differences in batch manufacturing.[1] The FDA also investigates reported side effects with a brand or generic product to determine if manufacturing changes are needed.

What is the Difference Between a Generic Product and an Authorized Generic?

A generic product is the equivalent of a branded product made by a company separate from the company that makes the brand product. An authorized generic, however, may be marketed by the brand-name drug company or company with the brand's permission but as a generic at a lower cost. Authorized generics are the same as the brand-name drug in that they have the same active and inactive ingredients, but their appearance may differ.[7] An authorized generic may not be listed in the FDA's listing of generic medications, known as the Orange Book, since it is marketed under the brand's New Drug Application versus generic products, which are approved after submission of an ANDA.[7,8]

Both generics and authorized generics may be lower in cost when compared with branded medications since generic manufacturers do not have to complete the clinical trials that were required for branded products.

Is There Anything to Look out for When Switching From a Brand to a Generic Product?

Brand and generic medications are not allowed to look the same, due to trademark laws in the U.S. Differences in color, shape, size, and flavor, however, do not play a role in the way the medications work. As previously stated, variability does occur in batches but at very small, nonsignificant levels. For example, a large study comparing generics with brand-name medicines found small differences of only 3.5% in absorption into the body between generic and brand medicines.[9]