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 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 that when there was no authorized generic and no competition, thus benefiting consumers.
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.
- Federal Trade Commission (March 29, 2006). "FTC Proposes Study of Competitive Impacts of Authorized Generic Drugs". Archived from the original on 2008-04-16.
- Food and Drug Administration. "Office of Generic Drugs". Archived from the original on 18 March 2011. Retrieved March 16, 2011.
- Don Sosunov. "Authorized Generics - Examination Under IP Law and Antitrust Law, Ministry of Justice, Israel." (PDF). Retrieved October 22, 2010.
- "#223: Authorized Generic Drug Study". FTC. August 2011.
- "Authorized Generic Drugs: Short-Term Effects and Long-Term ImpactAuthorized Generic Drugs: Short-Term Effects and Long-Term Impact" (PDF). FTC. August 2011.
- The Gale Group (August 29, 2005). "Prasco Laboratories: Over 80 percent of Americans Want the Option of Authorized Generic Prescription Drugs; Research Underlines Consumer Demand to Have Authorized Generic Prescription Drugs Available.".
- The Gale Group (August 29, 2005). "Prasco Laboratories: Over 80 percent of Americans Want the Option of Authorized Generic Prescription Drugs; Research Underlines Consumer Demand to Have Authorized Generic Prescription Drugs Available.". Retrieved March 16, 2011.
- IMS Consulting (Spring 2006). "Assessment of AuthorizedGenerics in the U.S." (PDF). Archived from the original (PDF) on March 27, 2009.
- Hassett, Kevin A.; Shapiro, Robert J. (May 2007). "The Impact of Authorized Generic Pharmaceuticalson the Introduction of Other Generic Pharmaceuticals" (PDF).
- The Generic Pharmaceutical Association (July 31, 2006). "Independent Analysis Reveals that Authorized Generics are Bad for Consumers, Lead to Higher Pharmaceutical Prices".[permanent dead link]