Generic Drug Entry Prior To Patent Expiration: An FTC Study

This study examined whether the conduct that the FTC challenged, which was certain antitrust actions against brand-name and generic drug companies, represented isolated instances or is more typical, and whether the 180-day exclusivity and the 30-month stay provisions of the Hatch- Waxman Amendments are susceptible to strategies to delay or deter consumer access to generic alternatives to brand- name drug products. The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect brand- name drug product.