Why Buy Authorized Generics

Buy prescription drugs identical# to the brand name, at generic prices††

Authorized Generics: the difference

Authorized generics compete with other generics approved by the U.S. Food and Drug Administration (FDA), commonly known as regular generics. While all generic drugs must meet the same safety and effectiveness standards in order to get approved by the FDA, there are several differences between authorized generics and regular generics.

When compared to the Brand Drug

Authorized Generics

Regular Generics

Active Ingredient Strength & Dosage

Authorized generics and regular generics are both identical with respect to the active pharmaceutical ingredients, dosage form, strength, and route of administration.1

FDA Approval

Authorized generics exist under the same New Drug Application (NDA) as the Reference Listed Drug. Generally, regular generics rely on the brand’s safety and efficacy data in the brand’s NDA. Regular generics approval process does require regular generics to demonstrate bioequivalence to the brand product.2

Different*
Manufacturing

Most authorized generics are made in the same exact manufacturing facility as the brand-name drugs and to the same specifications as the brand products. Generally, each regular generic is made in a different facility by a different company. The generic manufacturer does not have access to the brand’s proprietary manufacturing process.

Different*
Active Ingredient Availability at the Site of Drug Action

As part of the regular generics approval process, regular generics must demonstrate that they are bioequivalent to the brand product, meaning the rate and extent to which the active ingredient becomes available at the site of drug action is not significantly different from the brand product.  The FDA criteria for bioequivalence allows for some differences vs. the NDA product within the parameters established by the FDA.2

Not significantly different
Inactive Ingredients

Regular generic inactive ingredients may be different than the brand.1

May be different*
Taste, Smell, Mouthfeel

Regular generics can have a different taste, smell, or feel in the mouth (for example, the coating of the generic may be different from the brand drug).1

May be different*
Size & Shape

Regular generics can have significant variations in size and shape. Regular generic drug companies may produce different sizes and shapes of the same drug, so one generic company’s drug has a different size and shape compared to another generic company’s drug. Authorized generics are generally identical to the brand; however, there may be differences in markings, colors, labeling, and packaging.

May be different*
Identical to the brand-name drug

You have a choice when it comes to prescription medications

Learn more about FDA-approved authorized generics.