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

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.