generic drugs

...Price Competition and Patent Term Restoration Act helps the inventor by extending the patent protection to receive all earnings (The Congress of the United States Congressional Budget 9). The expiration date for a patent gives a company right to apply to the Food and Drug Administration (FDA) to copy and sell a generic version. FDA is an act that protects public health by testing for safety, accuracy, and effectiveness such as prescription drugs (FDA Mission 1). If a company wish to produce generic version they must satisfy the requirements stated by the FDA. Although trademark law in the U.S. requires the generic version should have different color, flavor, and other inactive ingredients, it should be identical in quality, dosage, safety, and strength (FDA Consumer 1). Most importantly both drugs should be equal in the bioequivalence, it should act at the same rate. The bioequivalence of a drug is the absorbency of the active ingredients in a human’s body (The Congress of the United States Congressional Budget Office 12). If the generic drugs are not identical to the brand name drugs, the FDA will not allow the drugs to be made. To make sure that all companies meet FDA approval, the FDA conducts 500 inspections a year (FDA Consumer 1). When the generic companies make generic drugs, they sell them at half the price of the brand name versions. The generic versions are less expensive because the generic companies do not have the same developmental cost of inventing drug companies. Lower developmental cost allows the generic companies to sell at a lower price. In the year of 2000 generic drugs sold in the U.S. were around $11.3 billion (Pamela Bassett 1). According to the Congressional Budget Office, when the drug companies produce generic drugs, customers save around $8 to $10 billion a year (Pamela Bassett 1). Forty-four percent of the drugs are the generic versions (FDA Consumer 1). In the years of 2001 and 2005, 110 companies’ patent protection will expire, increasing generic companies’ sales rapidly (Pamela Bassett 1). Many consumers will chose to pay less for the medicine and will receive the same result rather than to purchase the brand name, which will make the generic companies wealthy. In 2000 the average price of generic drugs were $19.33 and the average of brand name drugs were $65.29 (Pamela Bassett 1). Brand name drugs are much more expensive because the brand name version go through additional testing than the generic version before the FDA can approve (Tufts University Health and Nutrition Letter 1). When selling at a high price, it makes up for all of the finical cost an inventor used. The price difference is a good explanation why consum...

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