Other firms are reaching for that proprietary promised land, such as Watson Pharmaceuticals of Corona, Calif., Pittsburgh-based Mylan Laboratories, and, closer to home, Sidmak Laboratories of East Hanover. The holy grail of the pharmaceutical industry is to get patent protection. . . . Although the reward for success is potentially lucrative, the risks inherent for branded drug companies come into play for these burgeoning specialty firms. Failed clinical trials, millions of dollars spent on development, and the possibility of regulatory denial add elements of uncertainty. Clinical trials take time . . .
Generic drugs are chemically identical to the brand-name products they are intended to replace.
Once a patent expires on a drug, manufacturers can apply to market generic versions. As with new prescription drugs, the U.S. Food and Drug Administration approves and regulates generics. The industry was revolutionized in 1984 when a federal law created a new approval process for generics. Drug companies devoted to manufacturing generics formed, and larger operators diversified, starting their own generic divisions. From being less than a fifth of all prescriptions issued in 1984, generics now make up nearly half.