Role of Innovator Product Characterization in Generic Product Development



Generic drug products are defined as drug products that are comparable to the innovator/reference listed drug products (RLD) in dosage form, strength, route of administration, quality and performance characteristics, and intended use. These products play a critical role in the healthcare systems and contribute to more than 50 % of the total prescriptions by volume. Generic products are accorded regulatory approval based on the concept of therapeutic equivalence to the RLD. Therapeutic equivalence comprises of pharmaceutical equivalence and bioequivalence. Speed to the marketplace is the key for success in generic market. Development of generic products can be accelerated by performing characterization of the RLD, also referred as de-formulation studies. These studies, related to quantification of critical excipients, and solid state characterization of the active pharmaceutical ingredient, could provide critical inputs for formulation development of generic products. This chapter highlights the role of innovator product characterization in accelerating formulation development of generic products. Role of such studies in simplifying regulatory approval process has also been highlighted.


Abbreviated new drug application Generic drug Innovator drug Reference listed drug Deformulation 



Abbreviated new drug application


Active pharmaceutical ingredient


Code of federal regulations


Fourier transform infrared spectroscopy


High performance liquid chromatography


Hydroxypropyl methylcellulose


High performance thin layer chromatography


Liquid chromatography-mass spectrometry


Microcrystalline cellulose


New drug application


Near infrared spectroscopy


NIR Chemical Imaging


Polyethylene glycol


Particle size distribution


Quality by Design


Reference listed drug


United States Food and Drug Administration


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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Department of PharmaceuticsNational Institute of Pharmaceutical Education & Research (NIPER)SAS NagarIndia
  2. 2.Technical Research & DevelopmentNovartis Pharma AGBaselSwitzerland
  3. 3.Department of Pharmacy PracticeThe University of ToledoToledoUSA

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