This paper examines generic entry into the Japanese pharmaceutical market. Relatively little is known about generic entry in regulated markets. Using micro data between 2003 and 2005, I find that generic entry is sensitive to the prescription pattern driven by the price regulation and healthcare...

With increasing frequency, generic drug manufacturers in the United States are able to challenge the monopoly status of patent-protected drugs even before their patents expire. The legal foundation for these challenges is found in Paragraph IV of the Hatch-Waxman Act. If successful, these...