Authorized generics are
prescription drugs
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The rea ...
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 respon ...
'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
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*Anda, Heilongjiang, a city in Heilongjiang, China
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Iran
*Anda, Iran, a village in Fars Province, Iran
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, prices were significantly lower that 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 a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ...
,
Sonecon, and
GPhA[
] have commissioned their own studies on authorized generics, furthering the competitive debate.
References
External links
FDA List of Authorized Generic DrugsFTC - Authorized Generics: An Interim ReportFTC - Statement of Chairman LeibowitzFTC - Concurring Statement of Commissioner Rosch
{{DEFAULTSORT:Authorized Generics
Pharmaceutical industry
Pharmaceuticals policy
Federal Trade Commission