Abstract
The US generic industry, with annual sales of more than US$22bn, is excited about the prospects and opportunities for the future. However, the industry must remain vigilant to efforts by some special interest groups that seek to delay the timely introduction of more affordable generic drugs today, and in the future. Among the issues that could affect the continued growth of the generic pharmaceutical industry are authorised generics; misuse of the Citizen Petition process; and imposition of measures in free trade agreements that could harm America's generic drug industry. While the generic industry is focused on ensuring a level competitive playing field by addressing these and other issues, it is also expending significant time and energy to open the door to the new, untapped opportunity for savings that would result from generic competition for expensive biopharmaceutical products.