Q and A on Generic Drugs

Question. Are generic drugs really the same as brand-name drugs, or are they cheap imitations?

Answer. Although many generic drugs are made in other countries, drugmakers must adhere to strict manufacturing requirements from the FDA in order to earn approval to distribute and sell their products in the United States. FDA regulations require that generic medications be made with the same standards of purity, stability, strength, and quality as corresponding brand-name drugs. A generic drug must demonstrate the same therapeutic effect as its brand-name counterpart, and its active ingredient must achieve the same concentration in the blood in order to be approved.

Question. Why do generic drugs and brand-name versions look different?

Answer. Generic drug manufacturers are required by law to make their drugs look different from brand-name products, so that consumers can easily tell them apart.

Question. Does every drug have a generic alternative?

Answer. No. Generally, when brand-name drugs are first introduced, they are patent protected for 17 years before a generic alternative can be manufactured. After 17 years, generic companies can introduce their version of the brand-name product, but only after they have been thoroughly tested and approved by the FDA.

Question. What kinds of companies make generic drugs?

Answer. When a brand-name drug's patent expires, other manufacturers are free to make the same drug and, after approvals, market generic bioequivalents. Many companies do this. In addition, in order to further protect its interests after a patent runs out, a manufacturer of a brand-name drug will not only continue to make the brand-name drug but will also produce a generic equivalent.

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