What Are Authorized Generics?

You’re probably familiar with generics as a lower-cost alternative to brand-name medications. But a generic typically doesn’t become available until the brand’s patent has expired. One exception to this is an authorized generic — a brand-name medication without the brand name on its label.

But what exactly is an authorized generic? And how is it different from a regular generic? We explore the answers to those questions and more below.

What is an authorized generic?

Regular generic medications have the same active ingredient as their brand-name counterparts. They’re also required to have the same dosage, route of administration, and quality. Authorized generics have all of this, too. But authorized generics also have the same inactive ingredients as the brand-name version.

An authorized generic is exactly the same as the brand-name medication. But you may notice that it’s a different color, or that it has specific markings so you can tell the difference between the two. 

Who can make an authorized generic?

Not everyone can manufacture an authorized generic. An authorized generic is typically made available one of two ways:

1. The brand manufacturer makes the authorized generic product itself. The authorized generic may then be marketed by the brand manufacturer or a different company.

2. The brand manufacturer gives another manufacturer its exact recipe for the medication. In this case, the other manufacturer makes and markets the authorized generic. 

Authorized generics don’t need to go through the same approval processes as brands or regular generics. Instead, the manufacturer just needs to notify the FDA when one is going to launch. An authorized generic can be made available at any time, but it’s usually just before or after regular generics are on the market.

Examples of authorized generics

Not all brand-name medications have authorized generics. But here are a few examples:

• Prasco Laboratories’ colchicine, an authorized generic of Colcrys

• Watson/Actavis’ methylphenidate ER, authorized generic of Concerta

• Greenstone Pharmaceuticals’ celecoxib, an authorized generic of Celebrex

• Jerome Stevens Pharmaceuticals’ levothyroxine, an authorized generic of Unithroid

Is an authorized generic the same as the brand medication?

Yes. An authorized generic uses the same recipe as the original brand-name medication.

As mentioned above, an authorized generic may have a different color or markings on it. It may also have a different label or packaging. But these small changes won’t affect how the medication works. It also won’t increase your risk for side effects.

Is an authorized generic the same as the generic medication?

Authorized generics have the same active ingredient(s) as regular generics. But they don’t always have the same inactive ingredients. Examples of inactive ingredients include:

• Dyes, like FD&C Blue No. 1 and FD&C Red No. 40

• Flavorings

• Preservatives, like tocopherol (vitamin E) and ascorbic acid (vitamin C)

• Binders (to hold the tablet together), like cellulose and gelatin

• Fillers, like lactose and corn starch

The main difference is that an authorized generic is the same as the brand-name product. A regular generic provides similar benefits and risks, but it’s made using a different recipe.

What are the benefits of authorized generics?

Authorized generics can have a few benefits over either brand medications or regular generics.

Cost

Authorized generics offer you the exact same recipe as the brand medication, but at a lower cost. It’s also possible that your copay could be less with an authorized generic, but that may depend on your insurance plan.

Inactive ingredients

Authorized generics can also be a great choice if you have an allergy or intolerance to an inactive ingredient found in a regular generic. For example, if you’re living with celiac disease you may need to avoid the gluten found in some medications. Or if you’re avoiding animal products, you may want to steer clear of medications with gelatin or lactose.

Brand, authorized generic, and regular generics can all have these inactive ingredients. But if the brand medication doesn’t contain ingredients you’re trying to avoid, the authorized generic won’t either.

Specific drugs and dosage forms

For certain medications, the authorized generic may have unique benefits over regular generics. This can include narrow therapeutic index drugs and those with special modified-release dosage forms.

Narrow therapeutic index drugs: These are medications where a small change in your dose can affect how well they work and your chance of side effects. For some people taking these medications, switching from the brand to a regular generic can be problematic. Authorized generics can give you the consistency of the brand medication at a lower cost.

Modified-release dosage forms: Sometimes, medications made with certain modified-release dosage forms can be difficult for generic manufacturers to copy. For example, the FDA recalled some generic versions of Concerta in 2016 for this reason. In this case, the generics didn’t deliver the drug the same way as the brand.

Lower likelihood of switching back to brand

One study found that people who switched from a brand medication to an authorized generic were less likely to switch back compared to those who switched to regular generics. This was true for all seven medications included in the analysis.

However, this study didn’t look at why people switched back to the brand medication. So, we don’t know for sure if it’s due to preference or because they had a problem with the generic. Still, if you switch to a generic and aren’t getting the results you want, you may want to consider an authorized generic if it’s an available option.

How can I get an authorized generic?

If you’re currently taking a brand-name medication, check with your pharmacist to see if an authorized generic is available. The FDA also keeps an updated list of authorized generics on its website that you can view. 

Even though it’s the same as the brand medication, your healthcare provider will need to allow your pharmacist to substitute your prescription with an authorized generic.

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Written by:

Alex Evans, PharmD, MBA

Alex Evans, PharmD, MBA, has been a pharmacist for 12 years. His first job was floating in a community chain pharmacy.

Edited by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Stacia Woodcock, PharmD

Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.

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