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Ernst R. Berndt, Richard Mortimer, Ashoke Bhattacharjya, Andrew Parece, and Edward Tuttle Authorized Generic Drugs, Price Competition, And Consumers’ Welfare Health Affairs, May/June 2007; 26(3): 790-799. [Abstract] [Full Text] [Figures Only] [PDF] [Online Supplement] [Reprints & Permissions]

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No Proper Definitions Of Authorized Generics

Manthan D. Janodia, Dharmagadda Sreedhar, Virendra S.Ligade, Ajay G.Pise, N.Udupa   ( 14 May 2007 )

Authorized Generics And Their Effects On The Pharmaceutical Market

Mangesh M. Chitrivekar   ( 22 May 2007 )

No Proper Definitions Of Authorized Generics 14 May 2007
Manthan D. Janodia, Lecturer Dept. of Pharmacy Management, Manipal College of Pharmceutical Sciences, Manipal University, Manipal, Dharmagadda Sreedhar, Virendra S.Ligade, Ajay G.Pise, N.Udupa Send comment to journal: Re: No Proper Definitions Of Authorized Generics manthan.j{at}manipal.edu Manthan D. Janodia, et al.	This article highlights the benefits of authorized generics to consumers. However, as of now there is no widely accepted definition of authorized generics, nor is any given by any regulatory agency such as the U.S. FDA. Further, marketing of authorized generics is a tactic used by MNC companies to thwart the presence of other generic manufacturers. Moreover, certain amendments in the Hatch-Waxman Act, such as approval of generics for 180 market exclusivity for ANDAs that are filed on the same day, would allow the market forces to determine the prices of generic drugs, which eventually would benefit consumers. In addition, MNC pharmaceutical companies somehow try not to lose their market share once the patent on a blockbuster product is expired -- this more so in the case of drugs with higher sales revenue than those drugs having proportionally less sales revenue for the company. Additionally, there is no strong evidence to show that authorized generic drugs have had a major impact on consumers in terms of price benefits when compared with branded drugs.
Authorized Generics And Their Effects On The Pharmaceutical Market 22 May 2007
Mangesh M. Chitrivekar, Student Manipal University, Karnataka Send comment to journal: Re: Authorized Generics And Their Effects On The Pharmaceutical Market mangeshc2004{at}gmail.com Mangesh M. Chitrivekar	The article reveals that authorized generic drugs provide benefit to consumers. Authorized generic drugs are launched by innovator companies to save revenue which would be grabbed by the first ANDA filer company. The authorized generic drugs are generally launched during a drug's 180-day exclusivity period or simultaneously on the first day when the first ANDA filer launches its generic version. Actually, the intent of authorized generic drugs is not to provide benefits to consumers but because of competition and to capture market share by keeping their the drug price low. Innovator companies launch authorized generic drugs to discourage the generic companies from challenging patented drugs. By launching authorized generic drugs during the 180-day exclusivity period, they are violating a provision of the Hatch Waxman Act. If the authorized generic practices are allowed to continue, the generic companies are discouraged from challenging patented drug. Fewer ANDAs with Paragraph IV certification will be seen, and ultimately consumers will be harmed in the future.