Generic Drug

Generic drugs, sometimes known colloquially as generics, are drugs that are bioequivalent to a brand-name drug with respect to the pharmacokinetic and pharmacodynamic properties. However, because of the registration of brand-name drugs, generic drugs tend to be sold at a much lower price, enabling health service providers and customers to make substantial savings. Generic drugs and medicines have to have exactly the same active ingredient as the brand-name versions and must meet identical pharmacopeial requirements for preparation. They also must be of exactly the same strength and use the same method of administration, safety, efficacy, and intended use.

The sole reason for the use of generic drugs is to allow drugs to be made at a much cheaper price or to make drugs available that are not elsewhere for whatever reason. The reason why they are cheaper is that the company making the generic drug has generally not been involved in the extremely expensive research and development of drugs, the costs associated with obtaining regulatory approval in various countries, [Page 713]and also the cost of marketing these drugs, and making medical professionals around the world aware of their existence and use. As a result, makers of generic drugs do not have to go through the lengthy process of developing drugs and spending resources on drugs which are later found to be unsuitable. Furthermore, they do not need to undertake clinical trials—the test for a generic drug is solely that it has exactly the bio-equivalent makeup as the original.

Generic drugs allow drugs to be made at a much cheaper price and make drugs available that are not elsewhere.

The making of generic drugs is legal in three circumstances. The first and major use is when the original patent for the brand-name drug as expired or there has never been a patent issued. The second instance is when the generic company certifies that the original brand-name drug patents are invalid, unenforceable, or will not be infringed. Generic drugs are also made when the patent for the brand-name drug is not enforceable in the country where the generic drugs is being manufactured and sold. To preempt the expiry of patents, many drug companies producing brand-name drugs produce their own generic product or license their own product to be made by generic companies. In a few cases, some countries have also allowed their own manufacturers to produce generic drugs to treat major diseases when the health service of that country has not been able to fund the cost of brand-name drugs. This has happened recently in Brazil and Thailand.

Although generic drugs are said to be identical as brand-name drugs, in terms of having the same medical properties, some people have found adverse reactions to changing from medication with brand-name drugs to generic drugs. In some countries such as Australia, patients are allowed to ask for brand-name drugs or request that pharmacists substitute it with a generic drug to alleviate any of these problems, both actual and perceived.