What do you need to know about Generic Drugs?

Nearly 8 in 10 prescriptions filled today in the United States are for generic drugs, and the use of generic drugs is expected to grow over the next few years.  The brand name drugs are around 80-85% more expensive than the average generic drugs.  As a result, the persistent perception has been created that some generic drugs are inferior. Are brand name drugs actually better? The recent FDA publication Facts about Generic Drugs dispels this myth. Here is the brief overview of the article.

The same Quality and Performance

  • FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. Generic drugs are not required to contain the same inactive ingredients.
  • The generic manufacturer must prove its drug is the same (i.e. bioequivalent) as the brand-name drug. An example of equivalence is the same amount of drug in the bloodstream for both generic drug and the brand-name.
  • All manufacturing, packaging and testing sites must pass the same quality standards as those of brand-name drugs.

All Generic Drugs Must be Equivalent to the Brand-name Drug

  • Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug.
  • There will always be a slight, but not medically important, level of variability that occurs during manufacturing for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.

Why Generic Drugs are so less Expensive?

  • Generic manufacturers are able to sell their products for lower prices because they do not pay for the costly clinical trials of the new drugs, for advertising, or for marketing and promotion.
  • Multiple generic companies are often approved to market a single product. Competition in the marketplace often results in lower prices.

Here is a chart from FDA publication.  It is an excellent illustration of the points above.






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