What is a brand generic


Synonym: copycat preparation

1 definition

A Generic is a finished medicinal product that contains active ingredients that are no longer subject to patent protection (e.g. acetylsalicylic acid or doxycycline). It is mostly an "imitation" of an older original preparation, whereby galenics and pharmacokinetics can differ.

Generics are usually approved under the non-proprietary name of the active ingredient (INN), which also contains a manufacturer's name (e.g. Paracetamol-ratiopharm®). Likewise, off-patent active ingredients are known as Branded generics available under new registered trade names.

2 producers

In Germany there are several pharmaceutical companies that focus on the manufacture and sale of generic drugs, e.g. ratiopharm, Stada, Hexal and many others. Some of them offer a very broad spectrum of active ingredients from different specialist areas, while others specialize in certain groups of active ingredients such as antibiotics or drugs for the treatment of neurological-psychiatric diseases.

Internationally known generic companies include Teva, Watson and Ivax.

3 admission

For generics, simplified approval conditions apply in Germany. One also speaks of so-called "second applicant preparations", since generic manufacturers can refer to the documents of the original manufacturer when registering. This applies, for example, to the pharmacological-toxicological test results, the clinical studies and the expert reports. In order to ensure the effect, however, proof must be provided that the generic has the same bioavailability as the original preparation.

4 Economic importance

When the patent protection for important, high-selling drugs (e.g. antihypertensive drugs or lipid-lowering drugs) expires, generics from several companies usually come onto the market after a short time, and the original drug or related substances are increasingly being replaced by the prescribing doctors with the mostly cheaper generics. The entry of generics on the market therefore usually entails a price reduction for the original product.