Authorized generics are

prescription drugs A prescription drug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs ca ...

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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

's Office of Generic Drugs,

generic drugs A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...

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 2011 the FTC issued a final report on authorized generics (following its 2009 interim report) that showed that when innovator companies launched authorized generics during the 180 day exclusivity period granted to the first generic company to file an ANDA, prices were significantly lower than when there was no authorized generic and no competition, thus benefiting consumers.

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 Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is an American trade group representing companies in the pharmaceutical industry. Founded in 1958, PhRMA ...

, Sonecon, and GPhA have commissioned their own studies on authorized generics, furthering the competitive debate.

References

External links

FDA List of Authorized Generic Drugs

FTC - Authorized Generics: An Interim Report

FTC - Statement of Chairman Leibowitz

FTC - Concurring Statement of Commissioner Rosch
{{DEFAULTSORT:Authorized Generics Drug development Pharmaceuticals policy Federal Trade Commission