Authorized Generic Drugs: an Overview

Abstract

In the United States (U.S.), an authorized generic (AG) drug is essentially the approved brand-name drug (i.e., innovator drug), but marketed with a different name. Like independent generics, authorized generics (AGs) generally tend to cost less than their brand name counterpart, even though AGs are essentially identical to the brand. Most patients and health professionals are unaware of the availability of AGs even though they are commonplace. The launch of an AG has a financial impact on patients and on the competitive landscape of the pharmaceutical industry. Information regarding AGs is limited. The purpose of this study is to familiarize the reader with AGs. A review of the government documents and literature was conducted. The marketing of AGs has resulted, but not always, in benefits to the patient. AGs have been used as a tool in agreements between brand and generic companies. Countries have differing allowance and approval policies for AGs. AGs have played an important role in the healthcare system.