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Q and A on Generic Drugs

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

Answer: The FDA estimates that almost 8 out of every 10 prescriptions filled in the U.S. are generic. It is important to know that all manufacturers of brand name and generic medications must adhere to strict manufacturing requirements from the FDA in order to earn approval to distribute and sell their products in the U.S. FDA regulations require that generic medications be made with the identical active ingredient and adhere to the same standards of purity, stability, strength, safety, and quality as similar 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. Generic medications are usually substantially less expensive than brand-name products because generic drug companies do not have the same initial research costs, as well as advertising and marketing expenses, to pass on in their prices. The same is true for both generic prescriptions and over-the-counter drugs.  

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. Always ask your pharmacist, however, if your medications look different or if the name on the label is different from what you expect. Also ask if a less expensive generic form of medication is available for the prescription your doctor gave you. Always call your doctor or ask your pharmacist if your health condition changes after changing medications.

Question: Does every drug have a generic alternative?

Answer: No. Generally, when brand-name drugs are first discovered, they are patent protected for 20 years before a generic alternative can be manufactured. After research has proved the drug to be effective and it is approved by the FDA, most companies have only about 10 years of patent life remaining before generic companies can introduce their version of the brand-name product. Some medications are very difficult to manufacture or formulate and as a result, generic versions have not been introduced.

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 FDA approvals, market generic equivalents. Many domestic and international companies do this. These company's plants must follow the FDA's requirements for manufacturing, testing, packaging, and labeling. 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.