Imbruvica® is an important oncology drug.  Literature reported several polymorphs and solvates for drug substance Ibrutinib, including co-crystals with benzoic acid, fumaric acid, and succinic acid.   This poster examines viability of Ibrutinib co-crystal as an active ingredient for the follow-on generic drugs.  We will discuss recent FDA (February 2018) Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals and will provide approaches to demonstrate compliance to 505(j).  According to 505(j), an ANDA must contain the information to show that the proposed generic product (1) is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences) and (2) is bioequivalent to the RLD.

Approaches to demonstrate pharmaceutical equivalence of Ibrutinib cocrystal complex for the follow-on generic drugs

2019 Fall National Meeting

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