Leveraging 505(b)(2) to Innovate Beyond Existing Drug Patents
Drug Patent Watch
JUNE 24, 2024
The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route.
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