The ABCs of ANDAs: A primer on the generic drug approval process in the United States

摘要

The drug approval process for generic drugs in the United States is quite different from the process of most other countries. For non-US companies attempting to enter the US generic market, the learning curve can be quite steep. Even for US companies attempting to expand their markets, the process can be quite daunting.Perhaps the most unusual aspect of the generic drug approval process in the US is its tendency to encourage patent litigation. Understandably, most directors and officers of companies have a natural desire to avoid drawing lawsuits, as lawsuits in the US tend to be very expensive, not to mention that lawsuits are generally associated with having committed wrongful acts. In the limited area of generic drugs, however, lawsuits are intended to serve another function entirely. The purpose of the generic drug patent lawsuit (also known as a Hatch-Waxman litigation) is to encourage early entry of generic drugs to the market by providing an incentive to the first generic company to challenge a patent. Therefore, a Hatch-Waxman suit, seen in this light, is not a sign of having committed a wrong (1), but the sign of an aggressive generic company that understands such a lawsuit to be the cost of bringing affordable medicines to market.