title: Extensions of indication throughout the drug product lifecycle: a quantitative analysis.
abstract: The marketing authorisation of the first generic product version is an important moment in a drug product lifecycle. The subsequently changed intellectual property protection prospects could affect the incentives for further drug development. We assessed the quantity and nature of extensions of indication of small molecule medicinal products authorised through the European Medicines Agency throughout the drug product lifecycle with special attention for the impact of the introduction of a first generic competitor. The majority (92.5%) of the extensions of indication was approved during the exclusivity period of the innovator product. Regulatory rethinking might be needed for a sustainable stimulation of extensions of indications in the post-generic period of a drug product lifecycle.
authors.affiliation: Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Joris
authors.initials: J
authors.lastname: Langedijk
authors.affiliation: Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Whitehead
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Diederick S
authors.initials: DS
authors.lastname: Slijkerman
authors.affiliation: Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
authors.forename: Hubert G M
authors.initials: HG
authors.lastname: Leufkens
authors.affiliation: Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Schutjens de Bruin, Tilburg, The Netherlands.
authors.forename: Marie-Hélène D B
authors.initials: MH
authors.lastname: Schutjens
authors.affiliation: Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands. Electronic address: A.K.Mantel@uu.nl.
authors.forename: Aukje K
authors.initials: AK
authors.lastname: Mantel-Teeuwisse
mesh_terms: D058492:Drug Repositioning; D016568:Drugs, Generic; D005062:European Union; D018973:Intellectual Property
chemical_list: D016568:Drugs, Generic