Authorized Generics: What Are They Exactly?

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

When an authorized generic is available, it means that the company making the brand name product has either made a deal and given their exact recipe to a company that specializes in authorized generic products, or made the generic product themselves to be distributed by another company.

Will there be any differences between the brand medication and the authorized generic medication?

Yes. You may notice different tablet markings, taste, and label and packaging changes. However, these very small changes will not affect the experience you had with the brand.

How is an authorized generic medication different than a regular generic?

An authorized generic uses the same exact recipe as the original brand medication. Other generic medications use a similar recipe to the original brand medication but they are allowed to make changes to it. Regular generics may have different inactive ingredients, color, shape, and markings.

If you’ve ever switched from a brand to a generic when it approved, you know that these changes can make a huge difference in some patients—while in others they may not have any effect.

Are the recipes of most generic medications the same from one company to the next?

No. Generic medications can be made by several companies and the recipes can differ. Generic medications must contain the same active ingredient as the brand, but that is where the requirements end.

Can the generic manufacturer of my medication be changed by my pharmacy?

Yes. You may have noticed this if you’ve gone to the pharmacy for a refill and your generic medication looked different than what you received the month before.

If you’re concerned about any differences in your prescription, never hesitate to confirm with the pharmacist that you do have the same medication from a different manufacturer.

If possible, you should try to take the same generic from the same manufacturer each month—however, I know from experience that this is not always feasible.

Why does the pharmacy sell different generic manufacturers of my medication?

Pharmacies may not always be able to provide your prescription from the same generic manufacturer for a few reasons, including:

If there is a shortage or discontinuation, the wholesalers where pharmacies order their medications will send the same drug but from a different manufacturer.

Unfortunately, this can lead to confusion for you, the patient. The new generic may not look familiar, or may have different active ingredients.

What are some examples of authorized generics?

What are some companies that specialize in authorized generics?

Do all brand medications have authorized generics?

No. Not all brand medications have authorized generics. If you have a preference for authorized generics, it is important to research or ask your pharmacist to see if your newly generic brand medication has one available.

For more information and a list of authorized generics from the FDA check here.

What’s the takeaway?

Authorized generics are replicas of their brand-name drugs despite some small cosmetic changes. If you are worried about switching from your brand, using an authorized generic would be the next best option, letting you get the same exact medication at a lower cost.

Drugs featured in this story

Filed under