• Chaitanya Prasad K.
  • Prabodh M.
  • Ashish S.
  • Suthakaran R.
  • Naveen Reddy M.
  • Ravindra Reddy M.


Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming process most companies loss their patent exclusivity before drug gets marketing approvals. To prevent innovators from monetary losses occurred in drug development and to encourage innovation US FDA and EMEA introduced exclusivities under various categories.  Within the period of drug exclusivity no application is accepted either ANDA or 505 (b) (2).

Keywords: FDCA; EU; Exclusivity; FDA; EMEA; CDER; NDA; ANDA; Hatch Waxman Act.


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2. Lapointe S, Ph.D. Partner, Patent Agent, Comparison of the Non-patent Drug Exclusivities Available in the United States, Canada, Europe and Japan [Internet].The International Economic Forum of the Americas; 2012 June [Cited June 01]. Available from:
http://forum-americas.org/sites/default/files/ documents/20120614-lapointe-pres.pdf
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How to Cite
K., C. P., P. M., A. S., S. R., N. R. M., and R. R. M. “EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 2, Feb. 2018, pp. 21-25, doi:10.22270/ijdra.v2i2.128.