Exclusivity Strategies of Innovator Drug Developers

Chaitanya Prasad K ； 1Prabodh M ； Ashish S ； Suthakaran R ； Naveen Reddy M ； Ravindra Reddy M

《International Journal of Drug Regulatory Affairs》 2卷2期 (2014/06) Pp. 21-25

並列摘要

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).

並列關鍵字

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