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Carmeli C, Knyazeva MG, et al

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10 The 505(b)(2) pathway provides a regulatory route to overcome technical hurdles including stability, palatability, and manufacturing consistency, allowing firms to focus on improving drug performance rather than starting from zero. FDA 505(b)(2) Trend Analysis, 2025 14 The goal here is Defensive Innovation. By creating a differentiated productperhaps an oral liquid for patients with dysphagia or a longer-acting injectablea firm can bypass the innovators patents while offering a value story that payers will actually reimburse

There is no third party verifying identity, purity, or sterility, and no recourse if something is wrong