Generic drug

From Free net encyclopedia

A generic drug (pl. generic drugs, short: generics) is a drug which is bioequivalent to a brand name drug with respect to pharmacokinetic and pharmacodynamic properties, but is normally sold for a lower price. Generic medicines must contain the same active ingredient at the same strength as the "innovator" brand, be bioequivalent, and are required to meet the same pharmacopoeial requirements for the preparation. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use.

The principal reason for the reduced cost of generic medicines is that these are manufacturered by smaller pharmaceutical companies which do not invest in research and development into new drugs. The significant research and development costs incurred by the large pharmaceutical companies in bringing a new drug to the market is often cited as the reason for the high cost of new agents - they wish to recover these costs before the patent expires. Generic manufacturers do not incur these costs, with bioequivalence testing and the actual manufacturing process costing relatively little, and are able to charge significantly less than the "innovator" brand.

Generics can be legally produced for drugs where: 1) the patent has expired, 2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force. The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. It is also becoming popular for the large pharmaceutical companies to preempt the expiry of their patent by producing their own generic product, or license their own product to be branded by generic companies. Thus, in some cases, the "generic" product is actually the brand product but inside a different box.

1 Patent lifetime and research cost issues
2 Ensuring bioequivalence
3 See also
4 External links

[edit]

Patent lifetime and research cost issues

Pharmaceutical companies may produce a generic drug when the patent expires on the innovator drug. Patent lifetime differs from country to country. The length of time before a patent expires varies for different drugs. Usually, there is no way to renew a patent after it expires. A new version of the drug with significant changes to the compound could be patented but this will require new clinical trials and will not prevent the generic versions of the original drug. Usually, generic drugs are much less expensive than the brand-name product. Some patients and physicians will hesitate to prescribe these medications because of concerns about the quality of generic drugs. In most cases, the only differences between the brand-name product and the generics are the price and the name. When a pharmaceutical company first markets a drug, it is usually under a patent that only allows the pharmaceutical company that developed the drug to sell it. This allows the company to recoup the cost of developing that particular drug. It costs on average around 800 million dollars to develop and test a new drug before it is approved for use. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug. The brand-name drug companies have tended to litigate aggressively to extend patent protection on their medicines and keep generic versions off the market, a process referred to by critics as "evergreening."

[edit]

Ensuring bioequivalence

In the USA the Food and Drug Administration (FDA) is responsible for making sure that generic drugs are safe and effective. The approval process for generic drugs began in the late 1960s. Generic drug manufacturers were required to prove that their formulation exhibits bioequivalence to the innovator product. Over the past several years there have been studies that have proven without a doubt that generic drugs are safe and effective. Generic drugs are always less expensive and can save patients and insurance companies thousands of dollars without compromising the quality of care. The FDA must approve generic drugs just as innovator drugs must be approved.

[edit]