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Generic drugs are drugs that are manufactured and sold as a cheaper version of the brand named product. Whilst $4 generic drugs (http://www.medtipster.com) have not patented their active ingredient, their unique formulation may be patented.
The Food and Drug Administration of the United States of America governs all medications and according to them the generic drug is identical to the brand named drug, legally. Therefore, the same laws apply to generic drugs as their branded counterparts where strength, administration and safety are concerned. The $4 generic drugs (http://www.medtipster.com/genericdrugs.php) must contain the same active ingredient as the branded product and be within acceptable bioequivalent ranges.
Once the patent expires on a branded drug, generic drugs can be introduced into the market. This leads to competition on the market which brings down the price of both the generic and the branded drug.
Whilst patents are valid for 20 years on drugs in the USA, it is only really active for about a decade as developers have to apply for a patent before they begin with clinical trials.
Once a patent no longer protects a drug, generic drug companies can develop a similar product for a lot cheaper. This saves a lot of money for the generic company and enables them to market the product for a lot cheaper, hence the savings are passed onto health insurers and patients. Generic meds can be distributed within developing countries for a lot cheaper than the named brands.
India is the world leader in generic drug manufacturing and generic drugs are distributed from there to many developing countries. Generics are created by applying reverse engineering to brand named formulations to create bioequivalent generics thereof. Generics don't need to undergo clinical trials proving safety and effectiveness, which also saves time and money.
Generic drug companies leverage off the marketing efforts of the brand name drug, which after a number of years on the market has become well-known to healthcare professionals. These same professional can now easily switch over their patients from the branded product to the generic medication.
During the patent protection period, the brand name company monopolizes the market and therefore they can price the product in order to maximize profitability. Usually, during this time the drug is highly over-priced. This gives them the funds to research and develop new drugs. Most generic medication manufacturers cannot afford this.
Legally, generic drugs can be produced in the instances where either the brand name's patent has expired, when the generic manufacturer can certify that the brand name's patents are invalid, for drugs that have never held patents, or where the country does not enforce drug patents. Certain patents may only apply in certain countries.
When a patent expires, the monopoly is removed. Generally patents are not renewable. If the composition of a drug changes significantly in a new formulation, it will have to be patented again and new clinical trials will have to take place. If the original compound changes, the generic version with the original composition may still be sold unless it is taken off the market by regulators.
Developing countries import prescription drugs (http://www.medtipster.com) to distribute in their countries at low cost; hence prescription drugs (http://www.medtipster.com/genericdrugs.php) are welcomed by healthcare professionals and patients alike.
