Generic drugs economics

Bureau of Economics Staff Report, Federal Trade Commission, The Pharmaceutical Industry A Discussion of Competitive and Antitrust Issues in an Environment of Change (Mar. 1999) available at David Reiffen and Michael R. Ward, Generic Drug Industry Dynamics, Bureau of Economics Working Paper No. 248 (Feb. 2002) ( Reiffen and Ward ), available at... 

Reiffen, David, and Michael R. Ward. 2005. Generic Drug Industry Dynamics. Review of Economics and Statistics 87( l) 37-49. 

However, about 25% of the U.S. market for pharmaceuticals consists of generic drugs. All of these products are made outside the United States, and they are based on U.S. patents that have expired for successful products. Thus, the processing economics of high value added materials becomes important after a relatively short time period, and better design tools could make an impact on the industry. Similarly, the Imperial Chemical Industries philosophy of working on the design of the plant after next indicates... 

Office of External Affairs Office of Epidemiology and Biostatistics (CDER) Organization for Economic Cooperation and Development Office of the General Counsel Office of Generic Drugs (CDER, formerly DGB)... 

D. Reiffen and M. Ward, Generic drug industry dynamics. Federal Trade Commission Bureau of Economics (2002), http //www.ftc.gov/be/workpapers/industrydynamicsreiffenwp.pdf, accessed 6 May 2002. 

Despite high costs, studies on single enantiomeric development resulted in therapeutic and economic benefits, thus enabling pharmaceutical industry to submit patent applications on single optical isomers of long-used generic drugs [36]. 

Masson, A., and R. Steiner. 1985. Generic Substitution and Prescription Drug Prices Economic Effects of State Drug Product Selection Laws. Staff Report of the Bureau of Economics, FTC, Washington, DC, October. 

That documentation of pharmaceutical- and bio-equivalence should be provided to regulatory authorities is not at issue. However, the means by which these data can and should be demonstrated remain the subject of discussion. Political, economic and scientific hurdles pervade, and this issue remains unresolved. The imposition of existing small-molecule equivalence criteria on the registration of generic biologic drug products is unlikely to provide an acceptable degree of consumer protection. Likewise, the conventional bioequivalence trial used to infer therapeutic equivalence of different formulations based on the similarity of the phar-... 

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