title: 2004 update--180-day exclusivity under the Hatch-Waxman amendments to the federal Food, Drug, and Cosmetic Act.
abstract: This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.
authors.affiliation: Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C., USA.
authors.forename: Erika King
authors.initials: EK
authors.lastname: Lietzan
mesh_terms: D015507:Drugs, Investigational; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D007880:Legislation, Drug; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational