title: Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.
abstract: A "product hop" involves the substitution of a new formulation of a prescription drug by a pharmaceutical manufacturer for an old version to forestall generic competition. In 2015, for example, Forest Laboratories, the brand-name drug manufacturer of memantine, an Alzheimer's disease treatment, introduced an extended-release version and tried to restrict patient access to the previous version. Product hops can lead to useful incremental innovation but can also have major public health implications by disrupting patients on stable treatment regimens and increasing costs for patients and payers. This commentary reviews alleged anticompetitive product hopping in the case of memantine, which involved proposed conduct that would have left Alzheimer's disease patients with no effective choice but to transition to memantine XR. Policy solutions that can limit anticompetitive product hops include raising the bar for obtaining patents on new drug product formulations and changing automatic generic substitution laws.
  
  
  BACKGROUND
  No outside funding supported this research. To support his work at PORTAL in the summer of 2015, Capati was the recipient of the University of New Hampshire School of Law Rudman Center Public Service Fellowship. Kesselheim's research was supported by Greenwall Faculty Scholars program, the Laura and John Arnold Foundation, and the Harvard Program in Therapeutic Science. In 2013, Kesselheim served as an expert on behalf of a class of individual plaintiffs against Warner Chilcott regarding potential antitrust violations Kesselheim was responsible for concept and design of this commentary. Capati took the lead in data collection and analysis, along with Kesselheim. Capati wrote the manuscript, which was revised by primarily by Kesselheim, along with Capati.
authors.affiliation: 1 JD Candidate, University of New Hampshire School of Law, Concord, New Hampshire, and at the time this research was conducted was a summer Research Fellow, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Vincent C
authors.initials: VC
authors.lastname: Capati
authors.affiliation: 2 Associate Professor of Medicine, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy* / Q000191:economics; D003692:Delayed-Action Preparations; D004345:Drug Industry / Q000191:economics*; D057915:Drug Substitution / Q000191:economics; D016568:Drugs, Generic / Q000191:economics; D004465:Economic Competition / Q000331:legislation & jurisprudence*; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000191:economics / Q000600:supply & distribution; D006297:Health Services Accessibility; D006801:Humans; D007880:Legislation, Drug; D008559:Memantine / Q000008:administration & dosage* / Q000191:economics / Q000600:supply & distribution
chemical_list: D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D018691:Excitatory Amino Acid Antagonists; D008559:Memantine