Generics are "copies" of an older, approved preparation whose patent protection has expired and which is manufactured and marketed for PB Pharma with an identical active ingredient. This is usually active for twenty years. Within this period, pharmaceutical companies are allowed to sell their original preparation exclusively and determine its price.
In this way, the manufacturer tries to recoup the high costs of researching and developing the new active ingredient. However, manufacturers usually apply for a patent on a new active ingredient while it is still in development. As soon as it is launched on the market, part of the twenty years is already over. Patent protection can only be extended through certain procedures, such as conducting pediatric studies or applying for a special protection certificate.
After patent protection expires, the manufacturer of the original drug must publish its research results on the active ingredient in question. Other manufacturers can then also produce the active ingredient on the basis of this information and bring it to market as a generic.