Authorized generics

Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are required to contain only the identical active ingredients as the brand. Authorized generics compete with generics on price, quality and availability in the generic marketplace, and are marketed to consumers during and after what is commonly known as “the 180-day exclusivity period”.

In June 2009 the FTC issued an Interim Report that found that drug prices are lower when authorized generics are marketed against a single generic drug than when they are not. The report showed that with authorized generic competition during the 180-day marketing exclusivity period, retail drug prices are on average 4.2 percent lower than the pre-generic branded price, and wholesale drug prices are on average 6.5 percent lower than the pre-generic branded price.

Public studies

According to Roper Public Affairs & Media, 2005 public research underlines consumer demand to have authorized generic prescription drugs available, showing over 80 percent of Americans want the option of authorized generic prescription drugs. Several independent organizations, including Pharmaceutical Research and Manufacturers of America, Sonecon, and GPhA have commissioned their own studies on authorized generics, furthering the competitive debate.

External links

• FDA - Authorized Generics
• FTC - Authorized Generics: An Interim Report
• FTC - Statement of Chairman Leibowitz
• FTC - Concurring Statement of Commissioner Rosch