Drug patent live and generic competition: Analysis of new molecular entities approved by the FDA between 1980 and 1999

Enrique C. Seoane-Vazquez, Stephen W Schondelmeyer, Sheryl L. Szeinbach

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

This study estimates the patent life of new molecular entities (NMEs) approved by the U.S. Food Drug Administration (FDA) in the period 1980-1999 and analyzes the relationship between generic competition and patents listed in the FDA's Orange Book. A model was developed to describe and analyze the NME's patent life. A total of 340 NMEs were included in the analysis. The results of the study demonstrate an increase in post-new drug application patent time in the 1990s. Several factors explain this increase including reduction of the new drug application review time, pharmaceutical patent extensions, pediatric exclusivity, and changes in patent statutory term.

Original languageEnglish (US)
Pages (from-to)67-85
Number of pages19
JournalJournal of Pharmaceutical Finance, Economics and Policy
Volume16
Issue number4
DOIs
StatePublished - Jun 20 2008

Keywords

  • Drug exclusivity
  • Drug patents
  • New molecular entities

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