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

Kazuhisa Shimmura

Опубликована: Дек. 24, 2024

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

Язык: Английский

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

Kazuhisa Shimmura

Опубликована: Дек. 24, 2024

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

Язык: Английский

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