The Emerging 505(b)(2) Marketplace Provides Opportunities for Generic Companies Seeking New Revenue Streams in the U.S.

The "cliff" has passed for pharma, but has just begun for generic companies that have benefited from the high number of drugs going off patent. CEOs of generic companies report they are considering a spectrum of solutions to bridge the revenue gap, but perhaps none are more valid than the U.S. FDA’s 505(b)(2) approval pathway, which can offer accelerated approval, reduced development costs, lower risk and, in certain cases, market exclusivity. In this article, readers will get an understanding of 505(b)(2), why developers are choosing it, how products are identified and models for development.

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