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Forces persuade generic drug expansion in the United States

The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing.

Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics.

A generic drug is equivalent to it's brand name counterpart, but is usually much less expensive. A generic drug must have the same active ingredients, route of administration, dosage form, strength, and indications as the original brand product. Generic drugs are approved by the U.S. Food and Drug Administration, and are deemed to be as safe and effective as the brand name product.
Generics cannot be sold until after the drug patent expires on the original brand name product. For example, generic fluoxetine could not be sold until the patent had expired on the brand name equivalent Prozac. A drug manufacturer applies for a patent to protect their drug from being copied and sold by another company and losing profits.
Patents typically expire 20 years from the date of filing. During this period of patent protection, only the original manufacturer can research, develop and sell the brand name drug. When the patent expires, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market the generic version.

Generic drugs have lower research costs and increased market competition and those substantial savings are passed on to the patient. However, generic drugs still must meet strict FDA requirements with respect to quality, performance, labeling, manufacturing, and bioequivalence. By law, generic drugs must have the same active ingredients as the brand name product, and they can be expected to have the same effect when used in place of a brand name drug.
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