As major pharmaceutical companies’ patent monopolies over lucrative drugs wind down toward expiration, the legal maneuvering to keep generic competitors out of the market heats up.
As a patent is about to expire, generics makers can seek streamlined FDA approval if their drug is a bioequivalent of the patented version. One controversial means of delaying low-priced generics entering the market in recent years has been use of the regulatory process known as “citizen petitions” brought before the Food and Drug Administration, which temporarily halts generic approvals while the FDA investigates safety challenges raised in the petitions.
