Data exclusivity and pharma industry

The pharma industry conducts tremendous amount of testing (toxicological and clinical trials) and collects data to ensure that only safe products are introduced by them in the market. The industry supplies this data at extensive cost to regulatory authorities to meet their needs on safety and efficacy.

Data exclusivity (DE) means that during a certain period this proprietary data should not be disclosed and is used exclusively by the originator and protected from use by other to their commercial benefit (non-reliance). DE period usually runs concurrently to the patent period. Most countries have a five year period or more of data exclusivity.