EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS | Zendy

Chaitanya Prasad K. | Zendy; M. Prabodh | Zendy; S. Ashish | Zendy; R. Suthakaran | Zendy; Naveen Reddy M. | Zendy; Ravindra Reddy M. | Zendy

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EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS

Author(s) -

Chaitanya Prasad K.,

M. Prabodh,

S. Ashish,

R. Suthakaran,

Naveen Reddy M.,

Ravindra Reddy M.

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).

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