Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Brian Godman, Michael Wilcock, Andrew Martin, Scott Bryson, Christoph Baumgärtel, Tomasz Bochenek, Winne de Bruyn, Ljiljana Sovic Brkicic, Marco D'Agata, Antra Fogele, Anna Coma Fusté, Jessica Fraeyman, Jurij Fürst, Kristina Garuoliene, Harald Herholz, Mikael Hoffmann, Sisira Jayathissa, Hye Young Kwon, Irene Langner, Marija Kalaba & 19 others Eva Andersén Karlsson, Ott Laius, Vanda Markovic-Pekovic, Einar Magnusson, Stuart McTaggart, Scott Metcalfe, Hanne Bak Pedersen, Jutta Piessnegger, Anne Marthe Ringerud, Gisbert W. Selke, Catherine Sermet, Krijn Schiffers, Peter Skiold, Juraj Slabỳ, Dominik Tomek, Anita Viksna, Agnes Vitry, Corinne Zara, Rickard E. Malmström

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain - its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, historically generics can be legally prescribed for any approved indication once one indication loses its patent. Aim: To establish the current situation with pregabalin among health authorities principally from European countries. Methods: Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact, and collated into five tables. Results: The scenarios ranged from extending the patent life of Lyrica, e.g. France, endorsing the prescribing of Lyrica for neuropathic pain at the same price as the generic drug, e.g. Catalonia and South Korea, and current prescribing of pregabalin for all indications, e.g. Germany and Serbia. Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. Conclusion: The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.

LanguageEnglish
Pages125-135
Number of pages11
JournalGaBI Journal
Volume4
Issue number3
DOIs
Publication statusPublished - 1 Jan 2015

Keywords

  • Generics
  • Health authorities
  • Lyrica
  • Pregabalin

ASJC Scopus subject areas

  • Pharmacy
  • Drug guides

Cite this

Godman, B., Wilcock, M., Martin, A., Bryson, S., Baumgärtel, C., Bochenek, T., ... Malmström, R. E. (2015). Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future. GaBI Journal, 4(3), 125-135. https://doi.org/10.5639/gabij.2015.0403.028
Godman, Brian ; Wilcock, Michael ; Martin, Andrew ; Bryson, Scott ; Baumgärtel, Christoph ; Bochenek, Tomasz ; de Bruyn, Winne ; Brkicic, Ljiljana Sovic ; D'Agata, Marco ; Fogele, Antra ; Fusté, Anna Coma ; Fraeyman, Jessica ; Fürst, Jurij ; Garuoliene, Kristina ; Herholz, Harald ; Hoffmann, Mikael ; Jayathissa, Sisira ; Kwon, Hye Young ; Langner, Irene ; Kalaba, Marija ; Karlsson, Eva Andersén ; Laius, Ott ; Markovic-Pekovic, Vanda ; Magnusson, Einar ; McTaggart, Stuart ; Metcalfe, Scott ; Pedersen, Hanne Bak ; Piessnegger, Jutta ; Ringerud, Anne Marthe ; Selke, Gisbert W. ; Sermet, Catherine ; Schiffers, Krijn ; Skiold, Peter ; Slabỳ, Juraj ; Tomek, Dominik ; Viksna, Anita ; Vitry, Agnes ; Zara, Corinne ; Malmström, Rickard E. / Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future. In: GaBI Journal. 2015 ; Vol. 4, No. 3. pp. 125-135.
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abstract = "Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain - its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, historically generics can be legally prescribed for any approved indication once one indication loses its patent. Aim: To establish the current situation with pregabalin among health authorities principally from European countries. Methods: Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact, and collated into five tables. Results: The scenarios ranged from extending the patent life of Lyrica, e.g. France, endorsing the prescribing of Lyrica for neuropathic pain at the same price as the generic drug, e.g. Catalonia and South Korea, and current prescribing of pregabalin for all indications, e.g. Germany and Serbia. Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. Conclusion: The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.",
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Godman, B, Wilcock, M, Martin, A, Bryson, S, Baumgärtel, C, Bochenek, T, de Bruyn, W, Brkicic, LS, D'Agata, M, Fogele, A, Fusté, AC, Fraeyman, J, Fürst, J, Garuoliene, K, Herholz, H, Hoffmann, M, Jayathissa, S, Kwon, HY, Langner, I, Kalaba, M, Karlsson, EA, Laius, O, Markovic-Pekovic, V, Magnusson, E, McTaggart, S, Metcalfe, S, Pedersen, HB, Piessnegger, J, Ringerud, AM, Selke, GW, Sermet, C, Schiffers, K, Skiold, P, Slabỳ, J, Tomek, D, Viksna, A, Vitry, A, Zara, C & Malmström, RE 2015, 'Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future', GaBI Journal, vol. 4, no. 3, pp. 125-135. https://doi.org/10.5639/gabij.2015.0403.028

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future. / Godman, Brian; Wilcock, Michael; Martin, Andrew; Bryson, Scott; Baumgärtel, Christoph; Bochenek, Tomasz; de Bruyn, Winne; Brkicic, Ljiljana Sovic; D'Agata, Marco; Fogele, Antra; Fusté, Anna Coma; Fraeyman, Jessica; Fürst, Jurij; Garuoliene, Kristina; Herholz, Harald; Hoffmann, Mikael; Jayathissa, Sisira; Kwon, Hye Young; Langner, Irene; Kalaba, Marija; Karlsson, Eva Andersén; Laius, Ott; Markovic-Pekovic, Vanda; Magnusson, Einar; McTaggart, Stuart; Metcalfe, Scott; Pedersen, Hanne Bak; Piessnegger, Jutta; Ringerud, Anne Marthe; Selke, Gisbert W.; Sermet, Catherine; Schiffers, Krijn; Skiold, Peter; Slabỳ, Juraj; Tomek, Dominik; Viksna, Anita; Vitry, Agnes; Zara, Corinne; Malmström, Rickard E.

In: GaBI Journal, Vol. 4, No. 3, 01.01.2015, p. 125-135.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

AU - Godman, Brian

AU - Wilcock, Michael

AU - Martin, Andrew

AU - Bryson, Scott

AU - Baumgärtel, Christoph

AU - Bochenek, Tomasz

AU - de Bruyn, Winne

AU - Brkicic, Ljiljana Sovic

AU - D'Agata, Marco

AU - Fogele, Antra

AU - Fusté, Anna Coma

AU - Fraeyman, Jessica

AU - Fürst, Jurij

AU - Garuoliene, Kristina

AU - Herholz, Harald

AU - Hoffmann, Mikael

AU - Jayathissa, Sisira

AU - Kwon, Hye Young

AU - Langner, Irene

AU - Kalaba, Marija

AU - Karlsson, Eva Andersén

AU - Laius, Ott

AU - Markovic-Pekovic, Vanda

AU - Magnusson, Einar

AU - McTaggart, Stuart

AU - Metcalfe, Scott

AU - Pedersen, Hanne Bak

AU - Piessnegger, Jutta

AU - Ringerud, Anne Marthe

AU - Selke, Gisbert W.

AU - Sermet, Catherine

AU - Schiffers, Krijn

AU - Skiold, Peter

AU - Slabỳ, Juraj

AU - Tomek, Dominik

AU - Viksna, Anita

AU - Vitry, Agnes

AU - Zara, Corinne

AU - Malmström, Rickard E.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain - its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, historically generics can be legally prescribed for any approved indication once one indication loses its patent. Aim: To establish the current situation with pregabalin among health authorities principally from European countries. Methods: Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact, and collated into five tables. Results: The scenarios ranged from extending the patent life of Lyrica, e.g. France, endorsing the prescribing of Lyrica for neuropathic pain at the same price as the generic drug, e.g. Catalonia and South Korea, and current prescribing of pregabalin for all indications, e.g. Germany and Serbia. Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. Conclusion: The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.

AB - Introduction: The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain - its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, historically generics can be legally prescribed for any approved indication once one indication loses its patent. Aim: To establish the current situation with pregabalin among health authorities principally from European countries. Methods: Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact, and collated into five tables. Results: The scenarios ranged from extending the patent life of Lyrica, e.g. France, endorsing the prescribing of Lyrica for neuropathic pain at the same price as the generic drug, e.g. Catalonia and South Korea, and current prescribing of pregabalin for all indications, e.g. Germany and Serbia. Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. Conclusion: The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.

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KW - Health authorities

KW - Lyrica

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