Authorized generics

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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;[1] 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.[2] 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”.[3]


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.[4] 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[edit]

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.[5] Several independent organizations, including Pharmaceutical Research and Manufacturers of America,[6][7] Sonecon,[8] and GPhA[9] have commissioned their own studies on authorized generics, furthering the competitive debate.

References[edit]

  1. ^ Federal Trade Commission (March 29, 2006). "FTC Proposes Study of Competitive Impacts of Authorized Generic Drugs". 
  2. ^ Food and Drug Administration. "Office of Generic Drugs". Archived from the original on 18 March 2011. Retrieved March 16, 2011. 
  3. ^ Don Sosunov. "Authorized Generics - Examination Under IP Law and Antitrust Law, Ministry of Justice, Israel.". Retrieved October 22, 2010. 
  4. ^ Federal Trade Commission (June 2009). "Authorized Generics: An Interim Report". 
  5. ^ 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.". 
  6. ^ 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. 
  7. ^ IMS Consulting (Spring 2006). "Assessment of AuthorizedGenerics in the U.S.". Archived from the original on March 16, 2011. 
  8. ^ Hassett, Kevin A.; Shapiro, Robert J. (May 2007). "The Impact of Authorized Generic Pharmaceuticalson the Introduction of Other Generic Pharmaceuticals". 
  9. ^ The Generic Pharmaceutical Association (July 31, 2006). "Independent Analysis Reveals that Authorized Generics are Bad for Consumers, Lead to Higher Pharmaceutical Prices". 

External links[edit]