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2018 (v.26 no.2)

Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics
Quarter
ISSN: 2289-0882

  • Data exclusivity through New Drug Reexamination in Korea: sibutramine hydrochloride (Reductil®) vs. sibutramine mesylate (Slimmer®) as an example

    Howard Lee

    TCP | v.26, no.2, pp.49-55, Jun, 2018

    Abstract

    The ‘equivalent-or-more-but-not-the-same-data’ provision in the Regulation on the Safety and Efficacy Evaluation of New Drug in Korea has served as the de facto data exclusivity term for any drug identical to a product subject to new drug reexamination. The legal debate that occurred between Abbott Korea and Hanmi in association with the approval of their sibutramine products, i.e., Reductil® vs. Slimmer®, showed why data exclusivity plays an important role to protect intellectual property of the innovator drug when incrementally modified drugs had to rely on the safety and efficacy data of the innovator drug for approval. The regulatory science and legal issues regarding the case of Reductil® vs Slimmer® were discussed, and the importance of data exclusivity was emphasized
    as a useful tool to protect intellectual property besides patent.

    Keyword

    Data exclusivity, Intellectual property, New drug reexamination, Sibutramine