The future is tremendous: more than $13 billion worth of drug products will lose patent protection in the next year or so. Generics are taking advantage of the big win in the early Prescription Drug User Fee Act rush to review and approve all of these products. FDA is seeing the results of that now. There are multiple companies coming in for each one of the products going off patent.
The value of generics is the reduction in cost. FDA knows that if a drug costs less, it increases use and prevents shortages resulting from product rationalization or supply disruption. The biggest problem in drug shortages is economics. With product rationalization, a company that makes 90 percent of its sales from only 20 percent of its products can stop selling the other 80 percent of its products. As a result, there are many single-source generic products.
