Author Description

The practice of authorized generics has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An authorized generici 1/2sometimes termed a branded, flanking, or pseudo generici 1/2is a pharmaceutical that is marketed by or on behalf of a brandname drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products. These perceived disincentives result from the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. Better known as the HatchWaxman Act, this legislation provides independent generic firms with a reward for challenging patents held by brand-name firms. That bounty consists of a 180-day generic drug exclusivity period awarded to the first patent challenger. During the 180-day period, the brand-name company and the first generic applicant are the only firms that receive authorization to sell that pharmaceutical. At the close of this period, other independent generic competitors may obtain marketing approval and enter the market, ordinarily