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Extensions of indication throughout the drug product lifecycle: a quantitative analysis.
Langedijk, Joris; Whitehead, Christopher J; Slijkerman, Diederick S; Leufkens, Hubert G M; Schutjens, Marie-Hélène D B; Mantel-Teeuwisse, Aukje K.
Afiliação
  • Langedijk J; Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
  • Whitehead CJ; Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
  • Slijkerman DS; Medicines Evaluation Board, Utrecht, The Netherlands.
  • Leufkens HG; Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
  • Schutjens MH; Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Schutjens de Bruin, Tilburg, The Netherlands.
  • Mantel-Teeuwisse AK; Department of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands. Electronic address: A.K.Mantel@uu.nl.
Drug Discov Today ; 21(2): 348-55, 2016 Feb.
Article em En | MEDLINE | ID: mdl-26657087
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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Propriedade Intelectual / Reposicionamento de Medicamentos Idioma: En Revista: Drug Discov Today Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Propriedade Intelectual / Reposicionamento de Medicamentos Idioma: En Revista: Drug Discov Today Ano de publicação: 2016 Tipo de documento: Article