What in fact are generics? To clarify this, we first need to clarify what the original drugs – another often misinterpreted concept.
When a pharmaceutical company creates a new (original) product, it moisture average of 1.2 billion dollars of investment to develop its search of a molecule that will solve a health problem to the effective and safe treatment product on the market. Often this whole process takes about 15 years.
In order to obtain a pharmaceutical company ROI of funds invested in product development, it is necessary to take up additional years after the release of the already approved drug on the market. Therefore the regulatory bodies create conditions to protect the manufacturer from its competitive, which could get the formula for granted to enable him to recover the funds invested and to encourage the creation of new drugs in the industry in general.
The pharmaceutical company has created a new drug gets the exclusive right to produce and distribute for a given period, ie it owns the patent rights to the product. For the duration of the patent no other company can not produce competitive products containing the same active ingredient.
In most countries such as the US patent is issued for a period of 20 years. However, this usually happens before the registration of the product for use in phase t. Pomegranate. Clinical trials, i. E. In fact the original products under patent protection most often between 7 and 12 years after the placing on the market.
The huge initial investment inevitably affects the final price of the drug product. Namely taking advantage of this element of the marketing mix, generic pharmaceutical manufacturers are attacking the market for borrowing niche in it by shifting company creator of the drug.
Generic product means a product that has the same amount of the same active ingredient as the original, the same indication and virtually identical therapeutic effect. This means that the generic product must have the same (or within certain limits) action in the body compared to the original – it should deliver the same amount of active ingredient to be absorbed by the body at the same rate and extent as the original, to reaches the same or similar levels in the blood of the same or similar time as the original and show identical or nearly identical clinical effect. All this proves thoroughly the respective regulatory authorities prior authorization for the marketing of a generic product.