Download our latest paper: Breaking Down Complex Generics

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

Click here for the full paper or here to contact us for help with your complex drug development program.