regulatory exclusivity

Regulatory exclusivity refers to the period during which a pharmaceutical company has exclusive rights to market a new drug after it receives regulatory approval. This means that other companies cannot sell a generic version of the drug for a specified time, usually ranging from a few years to over a decade, depending on the type of drug and the specific regulations. This exclusivity helps companies recover their research and development costs, incentivizing innovation, while eventually allowing for generic versions to enter the market, which can lower prices and increase accessibility for patients.