Supergenerics Regulation in India and US: A Comparative Review

Authors

  • Achin jain Beloor Bayir Biotech Limited, Bangalore, Karnataka, India
  • Mudit Dixit Beloor Bayir Biotech Limited, Bangalore, Karnataka, India
  • Vasant Samaga Beloor Bayir Biotech Limited, Bangalore, Karnataka, India
  • B.G. Bairy Beloor Bayir Biotech Limited, Bangalore, Karnataka, India
  • M.P. Venkatesh 2Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore-570015, Karnataka, India

DOI:

https://doi.org/10.37591/rrjodfdp.v3i1.337

Abstract

‘Supergenerics’, a new form of generic drugs with improved properties such as safety, efficacy, stability or improved commercial attractiveness such as taste or route of administration. Those drugs are most often based on an incremental re-formulation of a generic API (active pharmaceutical ingredient) or the combination of multiple generic APIs. Process of forming supergeneric molecule need not to be complex all the time. A supergeneric may be as simple as a more advanced delivery system that increases effectiveness or makes delivery simpler like forming a skin patch for a drug commonly given by parenteral route. Supergenerics have different regulations in different regions of the globe. In this review, an effort has been made to summarize the requirement for supergeneric in India and US in a comparative manner.

 

Keywords: Supergenerics, New Drug, Patent extension

 

Cite this Article

Achin Jain, Mudit Dixit, Vasant Samagaet al. Supergenerics Regulation in India and US: A Comparative Review. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 30–38p.

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Published

2019-02-27

Issue

Vol. 3 No. 1 (2016)

Section

Review Article

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