Cocrystals: A Regulatory Rebirth

What is the impact of recent changes in FDA guidance on regulatory and intellectual property issues?
The FDA reclassification of cocrystals as active pharmaceutical ingredients (APIs) has created exciting opportunities for the pharmaceutical industry. That reclassification means cocrystals can now be developed as if they were polymorphs, providing new avenues for dealing with poor API physical properties and extending intellectual property lifetimes. It is important to understand how the revised guideline impacts API development, regulatory submissions, and intellectual property protection. Those topics are discussed in this whitepaper. Also considered is the importance of identifying whether an API is a salt or a cocrystal, a critical classification from a regulatory point of view. In addition, a list of FDA-approved, marketed cocrystals is presented. Finally, recommendations for cocrystal screening, evaluation, formulation, and production at scale are given.