EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS

Autor:	S Ashish, M Prabodh, K Chaitanya Prasad, M Naveen Reddy, R Suthakaran, M Ravindra Reddy
Rok vydání:	2018
Předmět:	Drug Innovator media_common.quotation_subject Business Marketing health care economics and organizations media_common
Zdroj:	International Journal of Drug Regulatory Affairs. 2:21-25
ISSN:	2321-6794 2321-7162
DOI:	10.22270/ijdra.v2i2.128
Popis:	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).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::9c6eb1122b9bb7481397fce2a28b8f50 https://doi.org/10.22270/ijdra.v2i2.128 Zobrazit plný text záznamu