Markets generics

In order to implement the NAS reports, FDA found that it must first address a number of important policy issues. First, FDA was required to determine whether the NAS findings would apply only to the pioneer drug for which the NDA was submitted or would also apply to all subsequently marketed generic versions of the drug. FDA determined that the latter approach was required, which led to extensive litigation. The FDA policy on this matter was ultimately upheld by the Supreme Court in June 1973. ... 

The programs designed to encourage generic utilization by payers have been very effective. In terms of the overall pharmaceutical market, generic... 

Italian company which was about to market generic Amikacin in Korea, they congratulated me, on the side, for our work on the Amikacin process. As soon as the Italian company s Amikacin appeared on the Korean market, we obtained samples and analyzed them. When the result came back showing that the Italian Amikacin contained the same profile of impurities as the Bristol-Myers product, and specifically that it contained no C-3-amino product, we were able to force the Italian product off the Korean market on the grounds of their infringement of the Bristol-Myers patent. 

European federation of pharmaceutical industries and associations 1643 European market, generic conversion rates and price 1766... 

Coal, considered a soHd hydrocarbon with a generic formula of CHq g, was explored by numerous workers (24—31) as a feedstock for the production of acetylene. Initially, the motivation for this work was to expand the market for the use of coal in the chemical process industry, and later when it was projected that the cost of ethylene would increase appreciably if pretroleum resources were depleted or constrained. 

Fig. 1), these are adjudged to be bioequivalent. The FDA sets the degree of similarity needed to be so termed. This concept is of obvious importance for the acceptance of generic dmg products for marketing. 

A marketed antibiotic s generic name is usually preferred because it is simpler and easier to remember. Tetracycline [60-54-8] is an example ... 

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

The sales of oral diuretics are declining, and are forecast to continue their decline in constant dollars during the 1990s (119,120). Several possible explanations can be offered for these trends. The patents of market leaders are expiring, lea ding to the introduction of generic brands at ca 40% below the cost of the branded market leaders physicians are switching to newer treatments for hypertension, eg, calcium channel blockers and... 

This will help to lead to a situation where generically-designated drugs are expected to account for 40% of the prescription drug market by 1990. 

As patents expire, exclusivity of producing a trade-nemed product will pass and competitive-versions of the basic drug will be marketed under generic names (or other new trade nemes) by new manufacturers. It has been estimated that 40% of the drugs on the market in 1990 will be generic drugs. 

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