Generic Pills
A generic pill is a pill wich is similar or equivalent to the original pill formula, but produced and sold under its International Nonproprietary Name (INN, chemical name of the molecule). The active molecule that does all their interest has been used for many years on a wide range of patients, are pills that treat trust property, safely, and they have a legal obligation to be as effective as the original pill. These generic pills can be produce after patent expiry, or in the absence of a patent. In contrast, a generic pill is sold for less.
According to the U.S. Food and Drug Administration (FDA), generic pills are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA’s use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic pills are available once the patent protections afforded to the original developer have expired. When generic pills become available, the market competition often leads to substantially lower prices for both the original brand name pill and the generic forms. The time it takes a generic pill to appear on the market varies. In the US, pill patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a pill patent tends to be between seven and twelve years.
The main reason for the low price of generic pills is that their manufacturing cost is not expensive, and therefore a lower price can be offered while ensuring its profitability.
The manufacturers of generic pills are mainly able to avoid the following three costs that brand name pharmaceutical companies incur:
- costs associated with research and pill development
- costs associated with obtaining the “regulatory approval” (proving safety and efficacy of the pill)
- and of course the (huge) marketing costs
First, the generic manufacturers do not incur the cost of drug discovery.
Second, manufacturers of generic Pills do not bear the burden of proving the safety and efficacy of drugs through clinical trials – but, they must prove the bioequivalence of the generic pill and the original pill.
Third, these labs selling generic pills are taking great advantage of marketing and advertising done by the creator of the original pill. Brand name pills must convince the consumer, generic ones do not.
The pills that generic manufacturers are selling have been on the market for at least ten years, and do not need additional advertising. For the same reason, generic manufacturers do not give samples to promote their products. The considerable costs of research, development and marketing costs incurred by large pharmaceutical companies during the introduction of a new pill to market are often cited as main reason for the high cost of new pill – they wish to recover these costs before the patent expires. Generic pill manufacturers do not incur these costs, with bioequivalence testing and manufacturing costs relatively low, and are able to significantly reduce their proces.





