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Generic Medicines: Quality medicines at affordable prices

Pharmaceutical companies patent the drugs that arise from their own research, which allows them to have a monopoly in the sales of their medicines for up to 20-25 years through use of multiple patents and extraordinary patent protection unique for the pharmaceutical sector. Originator products are also protected by supplementary marketing protection or "data and market exclusivity" for up to 11 years after receiving the first license or authorisation for marketing in EU. For the duration of the "data exclusivity" of an originator generic manufacturers can not apply for a market authorisation.

A generic medicine is a medicine that is developed to be the same or equal to a medicine that has already been authorised in EU (the original medicine or originator).
A generic medicine contains the same active substance(s) as the originator drug, and it is used at the same dose(s) to treat the same disease(s) as the originator medicine. However, the name of the medicine, its appearance (such as color or shape) and its packaging can be different from those of the originator drugs.

All pharmaceutical products approved for sale in EU are subject to the same strict inspections and quality control by governmental regulatory authorities.
The effectiveness and safety of a generic product is equal to that of the original patented medicine. The key factor in creating a generic medicine is to establish bioequivalence between the originator and the generic drug. Bioequivalence means that, when compared scientifically, the generic medicine and the originator product demonstrate essentially the same rate and extent of biological availability of the drug substance in the body when administered in the same dose. These scientific studies ensure that the patient does not experience different effect or safety when switching from the original drug to a generic drug.

A generic medicine is typically 20% to 90% less expensive than the brand-name original. In addition, the availability of lower-priced generic medicines brings down the price of originator drugs through market competition, producing even further savings to patients. The use of generic medicines saves European patients and healthcare systems an estimated €35 billion each year.

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