Open AccessEXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS
Author(s) -
Kumkum Prasad,
M Prabodh,
S Ashish,
R. Suthakaran,
Mahendra Reddy,
M Ravindra Reddy
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i2.128
Subject(s) - innovator , drug development , drug , business , marketing , process (computing) , drug approval , risk analysis (engineering) , generic drug , pharmacology , medicine , computer science , finance , entrepreneurship , operating system
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).