What are Complex Generics? Those that are inherently difficult to duplicate, are reviewed by CDER – OGD (not CBER), utilize the 505(j) Abbreviated New Drug Applications (ANDA) pathway, are generally off-patent, and represent markets with higher barriers to entry. According to Robert Lionberger, Ph.D. of OGD, Complex generics may be characterized by the following:
1. Complex Active Ingredients – low molecular weight heparin, peptides, complex mixtures, natural source products
2. Complex Formulations – liposomes, iron colloids
3. Complex Route of Delivery – locally acting drugs
4. Complex Drug-Device Combinations – dry powder inhalers, metered dose inhalers, nasal sprays, transdermal systems
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