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Supergenerics Regulation in India and US: A Comparative Review

Achin Jain, Mudit Dixit, Vasant Samaga, B. G. Bairy, M. P. Venkatesh



‘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 Samaga et 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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