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The Hidden Patents That Actually Decide When Generics Launch: A Strategic Analysis of Pharmaceutical Market Exclusivity

In the high-stakes world of pharmaceuticals, the launch of a generic drug isn’t just a matter of regulatory approval—it’s a complex chess game played behind closed doors, often invisible to the public eye. While headlines focus on patent expirations an…

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The Erosion of the Safe Harbor: Strategic Adaptation in the Era of “Label-Plus” Liability and Regulatory Rigor

In today’s rapidly evolving pharmaceutical landscape, the once-reliable “safe harbor” strategies that companies relied on are under unprecedented threat. The recent shifts in regulatory rigor, coupled with the rise of “label-plus” liability, are fundam…

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