OBJECTIVE To provide assistance for Chinese enterprises to market generic drugs in the U.S. market, to recognize the key factors affecting the revenue of products, combined with their own advantages, to establish effective sales strategies.

METHODS Based on public data such as the U.S. Food and Drug Administration Orange Book, the annual report of the U.S. Food and Drug Administration Office of Generic Drugs, the IQVIA database, annual reports of public listed companies, and the Pharmacodia database, descriptive statistical analysis and exemplification methods were mainly adopted.

RESULTS The generic drugs from different manufacturers in the U.S. market had strong substitutability, the price was closely related to the number of approved manufacturers.

CONCLUSION Chinese enterprises should closely monitor the number of competitors, launch the product as early as possible, establish lower cost ability and high pricing capabilities, so as to gain a greater market share in the U.S. generic drug market.