Evidence map›Paper›PMID 39003670›Full record

ArticlePharmaceutical medicine2024

Measuring and Understanding Market Exclusivity Length for New Prescription Drugs in France, Australia, and the USA.

Victor L Van de Wiele, Aaron S Kesselheim, Deborah Gleeson, Zhigang Lu, Sean S Tu, Benjamin N Rome

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Pharmaceutical medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Victor L Van de WieleFaculty of Law, University of Cambridge, The Sir David Williams Building, 10 West Road, Cambridge, CB3 9DZ, UK. vv306@cam.ac.uk.
Aaron S KesselheimProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Deborah GleesonSchool of Psychology and Public Health, La Trobe University, Melbourne, VIC, 3086, Australia.
Zhigang LuProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Sean S TuWest Virginia University College of Law, Morgantown, WV, USA.
Benjamin N RomeProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOriginator drug manufacturers use several strategies to delay generic competition in the USA, but it remains unclear whether this results in longer market exclusivity compared to other countries.

objectivesWe sought to understand how drug market exclusivity lengths vary between the USA and two comparable countries.

methodsWe focused on drugs approved within 2 years of each other in the USA, France, and Australia from 1995 to 2005, and we compared the lengths of exclusivity from marketing approval through first generic competition or June 2023 using Kaplan-Meier analyses.

resultsAmong 165 drugs in common between the USA and France, the median length of exclusivity was slightly longer in France (15.0 years, interquartile range [IQR]: 13.0-19.6) than the USA (14.5 years, IQR: 11.7-17.6). Among 100 drugs in common between the USA and Australia, the median length of exclusivity was longer in Australia (16.3 years, IQR: 13.9-22.4) than in the USA (14.4 years, IQR: 12.0-17.1).

conclusionsMarket exclusivity lengths in the USA are not longer than in France and Australia. Potential reasons include the larger US market and incentives that offer transient high generic drug prices in the USA for manufacturers that successfully challenge originator market exclusivity.

Indexed as

Drug IndustryDrugs, GenericPrescription DrugsAustraliaDrug ApprovalEconomic CompetitionFranceHumansMarketingTime FactorsUnited StatesDrugs, GenericPrescription Drugs

Identifiers

PMID39003670

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.