Are generic drugs as effective as the branded/original drugs? Why do they cost so much less? Surely the expensive drug must be better, somehow? These are some of the questions people often ask – certainly, it’s a controversial topic.

  • Brand-name/ethical/original/originator drugs refer to the drugs made by the manufacturer who first researched, developed, and sold the drug.
  • Generic/generic equivalent/no-name brand drugs refer to drugs made by other manufacturers – usually manufacturers who do not conduct research on new drugs but specialise in making/copying existing drugs.

It is common for the original developer/manufacturer of a drug to apply for a patent on the drug, which prohibits other companies from manufacturing the same drug – usually for a set period, say 10 years. It is when the patent expires that other manufacturers can “copy” drugs. This is why there are no generic copies of new drugs: the patents still apply.

Generic drug manufacturers usually sell their products for between 25% and 80% of the cost of the originator’s product, which can be a major cost saving to the patient.

Original drugs are much more expensive than generic drugs because the manufacturer has to offset all the development costs – development of a new drug can take up to 10 years and involve an enormous amount of laboratory, clinical, and safety testing. In fact, this is the reason patents usually extend over several years: to give such companies time to recoup their costs and encourage them to continue developing new drugs (without such ongoing development we would not have the array of amazing medications we see today).

The active ingredient in original and generic drugs is the same – only the fillers, binders, colouring and flavouring differ, which may explain why generics are sometimes a different size, shape, or colour.

All drugs, original and generic, go through testing to ensure quality, dose consistency, bio-availability (amount of the active ingredient available to the body) and experts generally agree that generic drugs are properly tested, reliable, and safe.

Generics are usually safe, but not always. Some drugs have a very narrow “dose range”, meaning that they are only effective, and safe, within a specific dose range – disease control might be compromised, or side effects precipitated, should the drug be outside the dose range (too much or too little drug). Generic drugs have very similar bio-availability (this is tested by the drug authorities before a generic can be registered) to the originals, but not exactly the same. For most drugs, this small difference is not important, but, in the case of certain drugs with a narrow dose range, this small difference can be important. Such drugs include:

  • Conjugated oestrogen (Premarin), prescribed as hormone replacement therapy for prevention of osteoporosis or heart disease risk.
  • Phenytoin (Epanutin) and carbamazepine (Tegretol) anticonvulsants.
  • Theophylline (Theo-dur), for asthma and lung diseases.

Most experts would discourage swapping between original and generic versions of these drugs, or would suggest very close monitoring of such swapping.

The manufacturers of original drugs perform valuable research and have developed many innovative, life-saving and life-changing drugs. Few would deny them some reward for this effort. However, health care is increasingly expensive and it is hard to ignore any opportunity to save some costs – going generic is one such opportunity. Besides certain drugs with narrow dose-ranges, it is usually safe and cost-effective to use generic drugs, although it would be wise to ask your doctor first.

Written by Dr Colin Burns