What Are Generic Medicines?
Generic medicines are copies of brand-name drugs that contain the same active ingredients and are deemed to be as safe as the brand to treat the same conditions. Generics, which are sold with their chemical names, have the same strength, are taken the same way and work in the same manner as the brand, according to the U.S. Food and Drug Administration. The big difference is that generic drugs cost less. They can save consumers 30 percent to 80 percent, according to the Generic Pharmaceutical Association.
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Cost of Generic Drugs
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Generics appear when drugs that have been on the market for many years lose their patent protection. Brand-name companies receive that protection to cover the cost of research and development, as well as marketing and advertising. Because generic manufacturers don't have development costs and simply are producing copies, they can sell their medications at big discounts, according to the FDA. When more generic companies make copies of the same drug, the price keeps falling because of increased competition, the Generic Pharmaceutical Association has said.
Safety and Efficacy
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Generic drugs must have the same active ingredients, though inactive ingredients like binders and flavors can be different. The FDA requires generics to work the same way in the body as brand-name drugs, and generics have the same benefits and risks. If a brand-name antibiotic could cause stomach upset, for example, the generic could cause that, too. The FDA requires the same high level of manufacturing processes at generic plants and notes that many brand-name drug companies also make generic drugs in the same plants. Generic drugs cannot look exactly the same as brand-name counterparts because of trademark laws.
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Incentives for Generics
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When the patented drug nears expiration, generic manufacturers prepare to make copies. The Drug Price Competition and Patent Term Restoration Act of 1984 allows the generic firms to apply for FDA approval without repeating the original manufacturer's lengthy and expensive animal and human clinical trials. The first generic company to apply for FDA approval, and receive it, is awarded 180 days of exclusive marketing. This can be a major advantage to that company because that exclusive period cuts out competition and helps the firm get its foot in the door with pharmaceutical distributors. After the 180 days, other generic companies receiving FDA approval can market their copies.
Prices and Popularity
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The average retail price of generic prescription drugs in 2007 was $34.34 compared with the average retail price of brand-name drugs of $119.51, according to The National Association of Chain Drug Stores. A survey conducted by IMS Health for the Generic Pharmaceutical Association showed that generic drugs saved the U.S. health care system $734 billion between 1999 and 2008. The survey also showed that generic drugs account for almost 70 percent of prescriptions dispensed in the United States. Because some generics have become so cheap, many stores with pharmacies nationwide are offering them at deeply discounted prices, and in some cases free, to lure customers.
Getting Generics
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By law, pharmacists throughout the United States have the right to substitute a generic version of a brand-name drug. Sometimes they won't even ask. But to make sure you get a generic, have the pharmacy clerk note that on your prescription. If for some reason you want the brand-name drug, you need to advise the clerk that you do not want the generic. Whether you have health insurance or not, the brand-name drug most likely will cost more.
Still to come
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No drug created by using a living organism has a generic copy in the United States because the FDA does not have the authority to approve them. These so-called biologic medicines usually are given by injection and used to to treat HIV/AIDS, cancer, Alzheimer's and other life-threatening diseases, are very expensive. The cost for treatment reaches tens of thousands or hundreds of thousands of dollars a year, according to the Generic Pharmaceutical Association. The association contends that copies of biologics would provide significant savings and is lobbying legislators to pass a law giving the FDA the right to set standards and approve copies.
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