• Vure Prasad
  • Pooja Kale


Now a day, big pharmaceutical companies with sustainable revenues are more interested in complex products to minimize competitions. In line with the originator companies, many generic companies are also focusing on complex products, either a specialized dosage form of already approved product or generic version of approved specialized products i.e. complex generics. Inherent ‘complexity’ involved in such specialized products insulates fierce competition and are considered as potential opportunities with high revenues. U.S FDA approved specialized products with proprietary technologies, such as nanoparticles, microspheres or liposomes are most promising dosage forms. These dosage forms are proven to be safer, while providing better efficacy as compared to historically approved simpler dosage forms, by ensuring targeted delivery of drug towards the infected cells. In the era of recent scientific advances, many generic companies are investing in abundance for the development of complex generics in the segment of targeted delivery systems like liposomes, therapeutic nanoparticles for treatment of various diseases such as cancers, inflammatory disorders, infectious and cardiovascular diseases. Despite potential opportunities reside in developing complex generics in terms of safety, efficacy and high revenue, no authoritative article has enlightened the challenges relating to regulatory, scientific, clinical, intellectual property (IP) and commercialization of complex generics. The present article makes an attempt to address the challenges involved in a regulatory approval of such complex generics involving potential opportunity with low competition.

Keywords: World Health organization (WHO); Low molecular weight heparins (LMWH); Intellectual Property (IP).


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How to Cite
Prasad, V., and P. Kale. “COMPLEX GENERICS: OPPORTUNITIES & CHALLENGES”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 3, Feb. 2018, pp. 1-10, doi:10.22270/ijdra.v4i3.184.