What are Authorized Generics?

Imagine the original Coca-Cola recipe in a plain bottle, for prescription drugs

4 min read • 2024-07-19

Most people have heard of Branded vs Generic drugs, where the latter can be cheaper and just as effective. Authorized generics are the little-known middle child of the generics discussion. The exact same product without branding, Authorized Generics may be your next option to consider.

What are Branded and Generic drugs?

Branded or brand-name drugs are developed and marketed under proprietary names by pharmaceutical companies. They undergo extensive research, development, and FDA approval. The drugs are protected by 20-year patents and multi-year exclutivity, preventing competitors from making the same products. The lack of competition allows the manufacturers to set a higher price and profit.

Generics are created to be equal substitutes as their brand-name counterpart. Once the patents expire, competitors may reverse engineer and market the same drugs, often under the active ingredient names. The generic drugs are the same as branded version in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. The generics are typically available at lower prices.

As a more relatable analog, Coca-Cola developed and marketed the original recipe, a branded Coca-cola in the iconic bottle and red label. With a strong brand and gigantic marketing budget, Coca-Cola is able to command a premium. However, many other companies also immitate and develop generic versions of the iconic soda, such as Walmart Sam's Cola, Whole Foods' 365 Cola, and Kroger's Big K Cola.

Now imagine Coca-Cola shares the mythical original recipe with another company or allows their current manufactueres to market a white label coke, this endorsed version would be the Authorized Generic.

What are Authorized Generics?

Authorized Generics are exactly the same as the branded version. Other than packaging, the drug and/or device are identical to the branded version. The authorized generic can be produced by the original manufacturer, or another company approved by the original brand. Instead of a new drug application, the original company must give the FDA notice for marketing an authorized generic. Authorized generics can offer the same branded recipe at a lower cost.

An example is fluticasone propionate inhaler, an authorized generic of Flovent endorsed by the original company GlaxoSmithKline. The left is the packaging of the branded Flovent, and the right is the one for authorized generic version:

Credit: National Library of Medicine - DailyMed

How to find Authorized Generics?

• FDA regularly updates a list of drugs with available Authorized Generics.
• Consult with your pharmacist for availability of authorized generic for your medications
• PillPointer searches over 2000 drugs for available
  Authorized Generic
  and options

As always, make sure to check your insurance formulary, ask for the cash price, and shop around pharmacies to get the best deal on your medications!

Have you tried an authorized generic drug? How did it compare to the branded or generic verions?

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