Originalläkemedlet

Originalläkemedlet refers to the first medicinal product containing a specific active substance that has been authorized for marketing. It is developed by a pharmaceutical company after extensive research and development, including preclinical and clinical trials to demonstrate its safety and efficacy. Once approved by regulatory authorities, it is granted market exclusivity for a certain period, during which other companies cannot market generic versions of the same drug.

The development of an originalläkemedlet involves significant investment in scientific research, drug discovery, and clinical testing. This process can take many years and is often costly. The exclusivity period aims to allow the innovator company to recoup its research and development expenses and to incentivize future innovation in the pharmaceutical industry.

After the patent protection expires, other pharmaceutical companies can develop and market generic versions of the originalläkemedlet. Generic drugs contain the same active ingredient, are administered in the same dosage form and strength, and are bioequivalent to the originalläkemedlet. They are typically sold at a lower price, increasing accessibility and competition in the market. Regulatory agencies ensure that generic drugs meet the same quality, safety, and efficacy standards as the originalläkemedlet before they are approved.