Authorized Generics compete with ANDA generic products. While all generic drugs must meet the same safety and effectiveness standards in order to get approved by the US Food and Drug Administration (FDA), there are several differences between Authorized Generics and ANDA generics.
Authorized Generics exist under the same New Drug Approval (NDA) as the brand. Other generics are approved by the FDA under an Abbreviated New Drug Application (ANDA). Generally, ANDA generics rely on the brand’s safety and efficacy data in the brand’s NDA. The ANDA approval process does require the ANDA generics to demonstrate bioequivalence to the brand product.2
Authorized Generics and ANDA generics are both identical with respect to the active pharmaceutical ingredients, dosage form, strength and route of administration.1
As part of the ANDA approval process, ANDA generics must demonstrate that they are bioequivalent to the NDA product, meaning the drug is tested to demonstrate it gets to the part of the body where the drug works in a time frame and amount that is not significantly different from the brand. The FDA criteria for bioequivalence allows for some differences vs. the brand within the parameters established by the FDA.2
Authorized Generics are manufactured in the same facilities and to the same specifications as the brand products. Generally, each ANDA generic is made in a different facility by a different company. The generic manufacturer does not have the exact understanding of the brand’s proprietary manufacturing process. Typically, a generic manufacturer reverse engineers the brand drug to determine the formulation and develops is own manufacturing process for the ANDA product.
ANDA generic inactive ingredients may be different than the brand.1
ANDA 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
ANDA generics can have significant variations in size and shape. ANDA generic drug companies may produce different sizes and shapes of the same drug, so one generic companies’ drug has a different size and shape compared to another generic companies’ drug. Authorized Generics are generally identical to the brand, however there may be differences in markings, colors, labeling, and packaging.
Because the drugs are identical to their brand-name counterpart, the experience will also be identical. Authorized Generics will have the same texture, taste, smell, feel, and side effects as the brand-name drugs.
Authorized Generics are always manufactured by the brand-name companies in the same facilities as their brand-name drugs; they are simply marketed as generics under a private label so the packaging and name are different.
The manufacture and marketing of Authorized Generics increase competition and help lower prices. In many cases, a consumer has multiple buying options for their prescription drugs – ANDA generics, Authorized Generics, and brand-name drugs.
ANDA generic drugs are required to have the same active ingredient, strength, dosage, form, and route of administration as the brand-name product, but not the same inactive ingredients, which may lead to a different patient experience when switching from a brand-name drug.