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What is the difference between a brand name drug and its generic counterpart?
When a pharmaceutical company develops a drug, it has to be approved by FDA (Food and Drug Administration) in order to be for its use to be permitted in the United States. The FDA makes sure that any drug produced meets standards of effectiveness, purity, safety and strength of the original drug. For the first 20 years after approval of a specific drug, other companies do not have the right to produce that specific drug. After 20 years, other companies are permitted to produce a generic version of the brand name drug under another label, i.e., generic name. However, in order for the FDA to approve the generic version or the new version of the drug , it has to follow the same guidelines as the original. The generic version and the brand name counterpart have to be the same in the active ingredients, the route of administration (the way it is taken) and the dosage amount. If these requirements are met, the drugs are said to be bieoequivalent. On the other hand, the two may differ in their inactive ingredients. This may be beneficial especially for those who may be allergic to the inactive ingredients of the brand name drug. The generic version can also differ in colour and shape which does not affect the efficacy of the drug. (Merck Manual, 6)
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Do they have they same effect?
Although some patients may claim that the brand name drug is better than its generic counterpart, the two drugs actually are the same.This is due to the fact that the generic version is not approved by FDA unless it goes through strict tests to show if the new generic version has the same therapeutic effect as the brand name counterpart of the drug. However, the difference in the efficacy some may experience can be due to the inactive ingredients slightly affecting the absorption of the drug. Furthermore, brand name drugs may have fewer or weaker side effects. (Generic and Brand name drugs, 4)
Generally, the generic version of a specific drug is less expensive than its brand name counterpart. The reason the brand name drugs are more expensive is because the company has to recover original cost of drug production. Some patients prefer the brand name drug over the generic counterpart (or vice versa) due to its taste, color, or other characteristics. (Generic Drugs Q & A, 5)
A brand name drug and its generic version are the same in bioequivalency and effect, and thus they can be used interchangeably in most cases. However, the doctor's or pharmacist's advice should be asked to prevent allergic reactions and other mistakes such as taking the wrong drug.
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- The Merck Manuals Online Medical Library Home Edition For Patients and Caregivers — http://www.merck.com/mmhe/sec02/ch01/ch017a.html
- Generic and Brand Name Drugs — http://www.med.umich.edu/1libr/aha/aha_genbrand_sha.htm
- Generic Drugs: Questions and Answers — http://www.fda.gov/cder/consumerinfo/generics_q&a.htm