What Are Generic Drugs? Are They Safe? Why Do They Cost Less?

Bipolar Medications Library

Wellbutrin SR and Generic Bupropion
Top: Wendy/Flickr. Bottom: National Institutes of Health

Brand Name vs. Generic Medications

In the United States, brand name medications are developed under patent protection. A drug company may spend years - decades, even - researching and testing before bringing a new drug to market. Leaving controversies over brand name drugs' high costs aside, a manufacturer's initial price for a new medication includes all the development costs it incurred for the drug.

Patents on brand name drugs generally last 10 to 20 years.

As the expiration date of the patent approaches, any drug manufacturer (including the one that produced the brand-name version) may apply for permission to produce a generic version of the medication. Companies making generic versions of medications do not have to:

  • Do the research that was needed to create the drug in the first place;
  • Put the drug through clinical trials; or
  • Set up marketing campaigns for the generic drug.

Eliminating these three factors from the cost of manufacturing the generic drug means that a generic can be sold at a far lower price than the brand-name version.

Requirements for Generics

According to the US Food and Drug Administration (FDA), "To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug (inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products"

For a drug to be bioequivalent to its brand name counterpart, it must deliver the same amount of the active ingredient(s) in the same amount of time as the original.



This does not mean that all characteristics of a generic medication are the same as the original brand name drug. A generic must not look like the original due to trademark protection. Also, inactive ingredients, flavors, fillers and dyes may be different from the brand name medication.

Problems With Generic Drugs

Most of the time generic drugs are just as safe and effective as their brand name counterparts, but problems can arise. The most common reason for difficulties with generic drugs is that the inactive ingredients or excipients are different. Epilepsy Newfoundland and Labrador, an information and advocacy organization, notes:

  • The active ingredient that helps control your seizures is the same in both 'brand' and 'generic' names but the substances that are used as fillers, dyes, or binders, sometimes differ. This can occasionally make a difference in how quickly they are absorbed from your stomach or processed by your body. This may affect how much medicine you need.

Some people are allergic to some excipients.

In addition, a person's body may have become accustomed to the entire mix of active an inactive ingredients in one manufacturer's drug, and changing the mixture - even if there is no allergy to a new ingredient - may cause a change in response to the medication.

Examples of problems with generics:

  • Kimberly's pharmacy changed from one generic manufacturer to another for one of her medications. For two weeks she experienced painful gas and diarrhea while her body adjusted to the new generic.
  • Marcia's pharmacy changed her prescription from Prozac to a generic version, fluoxetine. She broke out in a rash - apparently an allergic reaction to one of the excipients in the generic.

Precautions

You should not assume that you will have a problem when changing from brand name to generic or from one generic version of a drug to another. However, there are several steps you can take to minimize the risk of problems with generic medications, including noting the manufacturer on a list of your medication and checking the list each time you get a refill to see if the manufacturer has changed. For more, see Medication Safety Tips.

Disclaimer: This is not intended to be all-inclusive or to replace information provided by your doctor or with prescriptions from drug manufacturers.

References on Page 2

References:

Generic Drugs: Questions and Answers. Center for Drug Evaluation and Research (CDER), FDA. 2004. 7 Aug 2006.

Generic Drug. Wikipedia. 2006. 7 Aug 2006.

FDA-Approved Bargain Drugs: Generic Products Must Meet High Standards. U.S. Food and Drug Administration. 2003. 7 Aug 2006.

Questions About Generics. Medco. 2003. 7 Aug 2006.

Generic or Brand Name Medications. Epilepsy Newfoundland and Labrador. 2001. 7 Aug 2006.

Brownlee, C.L. Adding that "spoonful of sugar" and more. Modern Drug Discovery. 2002. 7 Aug 2006

Generic Drugs: Making the Switch. Aetna Pharmacy. 2006. 7 Aug 2006.

Hendershot, R. "Brand-Name Drugs, Generic Drugs, and Illegal Prescription Drugs." Linknet Articles. 2006. 14 Aug 2006. (No longer available)

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