The USA is the world’s largest pharmaceutical market, with total prescription drug sales exceeding US$200 billion at manufacturers’ prices. Generics have become widely used since the passing of the Hatch-Waxman legislation in 1984. They now account for around 50% of the market by volume. By value, however, generics only account for 8-10%. Their low price and the rapid pace of branded drug expenditure growth accounts for this.
The USA is home to some of the world’s largest generic manufacturers. Some of these, such as Barr, Mylan or Watson, now have annual sales exceeding US$1 billion. The major overseas players, such as Sandoz and Teva, have substantial US operations, augemented by major recent acquisitions of US companies.
We help Chinese companies to establish business model and apply for the permit from FDA.
