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Regulatory Data Exclusivity

Meaning

Regulatory data exclusivity is a non-patent-based intellectual property protection granted by regulatory authorities to the developers of new pharmaceutical products, preventing generic manufacturers from relying on the originator company’s clinical trial data to gain marketing approval for a set period. In the hormonal health sector, this exclusivity is crucial for innovative therapies, such as novel hormone delivery systems or unique combination products, as it provides a defined commercial advantage. This mechanism incentivizes significant investment in the rigorous and costly clinical research required for drug approval.