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US FDA’s New Paragraph IV Data Further Illustrates Generic Competition Problems

Arent Fox Counsel Brian Malkin was quoted in a recent Pink Sheet analysis about the Food and Drug Administration (FDA)’s new efforts at transparency in the generic drug space.

The FDA has recently begun to disclose the number of first applicant abbreviated new drug applications (ANDAs) for generic drug products. Brian, whose practice focuses on the interaction between patent and drug law, views the new data as a potential time-saving mechanism for both drug sponsors and the FDA, positing that “if this helps companies make decisions whether to develop and file ANDAs, and potentially reduce FDA’s review workload, it would be a win-win.”

Thus far, the data collected reveals a large variance in interest among generic drug products, where some generic markets are crowded and others have few (and sometimes only one) applicant. Products with more complex formulations (generally powders, liquids, nasal sprays, patches, and gel formulations) are drawing less interest in the form of ANDAs than products marketed as tablets and capsules. The FDA hopes that this new information, which is part of its Drug Competition Action Plan, will spur more generic development moving forward.

Read the full article here (Pink Sheet subscription required).


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