The Challenges of Complex Generics

White Papers of Drug Delivery  – Part 3/3
Christopher A. Rhodes (Ph.D), President & CEO of DDE Labs, Inc.
20 September 2019

Drug Delivery Technologies have been evolving with the development of pharmaceutics and biologics. 
With these 3 articles, Dr. Christopher Rhodes, CEO of DDE Labs,  describes the development and the frontline of Drug Delivery.
This is Part 3 of a Series of 3 segments.

(Table of content)
Part 1
    - The Hope for Oral Delivery of Biologics
Part 2
    - Renewed Interest in Long-Acting Injectable and Implantable Drug Products
Part 3
    - The Challenges of Complex Generics

Keywords for the article: Drug Delivery, Oral Delivery, Injectable, Implantable, Long-acting systems,


The Challenges of Complex Generics

Complex Generics

  Generic combination drug products are broadly characterized in the GDUFA II guidance and refer to oral products with more than one active, complex formulations such as liposomes, suspensions, emulsions, and gels, complex routes of administration such as locally acting products (topical creams and gels, nasal spray, and inhalation products), drug combinations with devices, long-acting injectables.  REF 1.  There is a nice list of complex generic product guidances which are going to take effect soon.  REF 2



Figure 1. Complex Generic Product Examples
1a. Cinvanti (aprepitant) injectable emulsion for intravenous use
1b. Primatene mist epinephrine inhalation aerosol
1c. Lidocaine generic Lidoderm 5% patch