Balance Mechanism Study between Brand-Name Drugs and Generic Drugs in American Drug Review / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 938-944, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-858324
ABSTRACT
OBJECTIVE:
To figure out the balance mechanism between brand-name drugs and generic drugs in American drug review.METHODS:
This paper reviewed FDA laws and regulations, domestic and foreign literature to retrospect the basis of generic development and explore the brand-name drug companies' action to prevent generic competition. RESULTS ANDCONCLUSION:
The abbreviate new drug application, patent challenge and market exclusivity in the Hatch-Waxman Act were the basis of generic development. Brand-name drug companies prevented competition by occupying the market, refusing to provide samples, submitting citizen petitions to extend generic drug review time and extending the patent term and market exclusivity of brand-name drugs. The United States legislated and amended relevant laws and regulations, adjusted the generic drug user fee to maintain the stability of the balance, which is worthy of further research.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2018
Type:
Article
Similar
MEDLINE
...
LILACS
LIS