Expanding Drug Indications: Strategic Lifecycle Management vs. Evergreening in SGLT2 Inhibitors

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Published: Jan 20, 2025
DOI: https://doi.org/10.5750/jipp.v1i1.2216
Keywords:
Lifecycle Management (LCM) strategies SGLT2 inhibitors patent protection chronic kidney disease (CKD) pharmaceutical regulatory frameworks drug indication expansion healthcare innovation international patent law

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Kazuhisa Shimmura
EUCALIA Inc., 19th Floor, Kasumigaseki Building, 3-2-5 Kasumigaseki, Chiyoda-ku, Tokyo, Japan

Abstract

In the rapidly evolving pharmaceutical industry, Lifecycle Management (LCM) strategies are critical for maximizing the profitability and extending the market life of drugs. This study investigates the strategic importance of expanding indications for sodium-glucose cotransporter 2 (SGLT2) inhibitors before the expiration of their foundational patents. By analyzing these pre-expiration strategies, the balance between genuine innovation and strategic evergreening is addressed. The analysis covers the legal, regulatory, and clinical dimensions of indication expansions across the US, EU, and Japan, contrasting with the traditional focus on LCM strategies post-patent expiration.

Article Details

Issue
Vol. 1 No. 1 (2024)
Section
Articles
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Author Biography

Kazuhisa Shimmura, EUCALIA Inc., 19th Floor, Kasumigaseki Building, 3-2-5 Kasumigaseki, Chiyoda-ku, Tokyo, Japan

Kazuhisa Shimmura serves as a Data Scientist at EUCALIA Inc., where he combines his expertise in data analytics with a profound understanding of intellectual property law, evidenced by his qualification as a patent attorney. Additionally, he is a PhD candidate at the Bio-Innovation Policy Research Unit, Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, the University of Tokyo, specializing in Life Sciences and Bioinnovation Policy Research. His academic and professional pursuits are centered around the strategic use of intellectual property in pharmaceuticals, epidemiological research using electronic health record databases, and technology transfer in academic settings. Through his work, Shimmura aims to bridge the gap between scientific innovation and its practical application, ensuring that advances in healthcare and biotechnology are effectively protected and utilized for the greater good.