|Generic drugs: Answers to common questions|
|Wednesday, 25 July 2012 00:00|
What’s the difference between generic drugs and brand-name drugs?
When medications are first approved by the US Food & Drug Administration, companies have an exclusive patent to sell them under a brand name. Patents typically expire after 20 years. After that, other manufacturers are free to make and sell “generic” versions of the same medication.
Generic drugs are “bioequivalent” to the brand-name version. This means they have the same active ingredients, in the same dose, delivered the same way, for example, by pill or syrup. Generic drugs may contain different inactive ingredients and preservatives, and they may look different than the brand drug.
Are generic drugs as safe and effective
as brand-name drugs?
Yes. The FDA tests to make sure that generics contain the same active ingredients as brand-name drugs. Generic drugs must be just as strong and stable as their brand-name equivalents. They must come in the same doses and carry similar labels. Generic drug manufacturers must follow the same strict FDA guidelines for good manufacturing practices that brand-name manufacturers follow.
Who makes generic drugs?
About half of all generic drugs are made by the same pharmaceutical companies that make brand-name drugs. The rest are made by manufacturers that specialise in generic drugs.
Why are generic drugs usually less expensive?
Developing and testing new drugs is time-consuming and expensive. After approval, manufacturers set a price that will pay back those costs and make a profit. When a drug goes generic, manufacturers don’t have to repeat the same expensive clinical studies. They only have to show that the generic drug is equivalent to the brand-name drug. The approval process is far less costly. As a result, generics cost about one-third as much as brand-name drugs, on average. According to the FDA, generics save consumers an estimated US$8 billion to US$10 billion a year at retail pharmacies.
Why do generic pills look different than the brand-name drug?
US trademark law requires that brand-name drugs and generic drugs look different. Differences in shape or colour don’t affect safety or effectiveness.
WebMD Medical Reference