Not all generic drugs are authorized, however, nor do they have to be.

Authorized generics have a six-month exclusivity period during which no other generic product can be marketed. Called “ authorized generics,” these drugs are covered under the branded drug’s New Drug Application (NDA) and FDA approval.

In fact, these generic drugs are typically marketed by the manufacturer of the branded drug or by an authorized agent of the manufacturer, but without the brand name. Some generic drugs are fully identical to their brand-name counterparts, with the exact same active and inactive ingredients. In addition, all generics must meet the same manufacturing and quality standards as the brand drug, and all must have FDA approval. Dosages, administration form and route, safety, effectiveness, strength, and most labeling are also the same. Generics have the same active ingredients as the brand drug, and the active ingredients are released into the bloodstream at virtually the same speed and in the same amounts as the original drug. What Do Generic Drugs Have in Common?Īll generic drugs do share certain characteristics. Understanding their differences and the MAC pricing implications is critical for choosing the most cost-effective pharmacy benefits manager for your company or health plan. Or is it? Generic versions of brand name medications are actually not all the same. A generic drug by any other name is still the same.

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