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Lifecycle Management Strategies: Reformulations - Success hinges on delivering significant improvement in disease outcome



This report analyzes reformulation as a brand lifecycle management strategy and includes an overview of the strategy with key success drivers and resistors and successful and unsuccessful case studies of reformulated brands.



Reformulation has been one of the dominant and successful lifecycle management strategies in the past but changes in the healthcare environment are hampering their success. However, reformulated products can still achieve commercial success provided they satisfy key stakeholder needs by providing significant improvements in disease outcomes.


  • Analysis of success drivers and resistors of reformulation as a lifecycle management strategy
  • Discussion of how reformulation can satisfy key stakeholder needs.
  • Case study of recent successful and unsuccessful reformulations.


  • In the past, reformulation was one of the most popular and successful lifecycle management strategies, with most companies launching reformulated versions of their first generation products shortly before patent expiry, and subsequently switching patients onto these in order to drive franchise sales.
  • However, with cost containment taking center stage in most markets, payers have introduced measures to restrict the use of reformulated products unless significant benefit in terms of disease outcome and compliance can be demonstrated.
  • It is critical that reformulations deliver tangible improvements in disease outcomes, with head-to-head trials against first generation versions necessary to demonstrate superiority key to successful uptake among both payers and physicians


  • How can reformulation drive or maintain franchise sales?
  • How have changes in the healthcare environment in the last few years made it more difficult for reformulations to achieve commercial success?
  • Can reformulations still be commercially successful and how?

Table of Contents


  • Introduction
  • Strategic scoping and focus
  • Key findings
  • Related reports


  • What is reformulation?
  • Drivers and resistors of reformulation
  • Regulatory issues to be considered when reformulating
    • Market withdrawal of the original product is an ineffectual tactic for delaying generics
    • Only robust reformulation patents can protect line extensions
  • Why and when reformulate?
  • Reformulated product must better satisfy key stakeholder needs
  • Case study summary


  • Astepro (once-daily azelastine; Meda Pharma): head-to-head trials lead to a successful switch
    • Lesson
    • Background
    • Impact
  • Lupron (leuprorelin; Abbott Laboratories): broad portfolio of formulations and brand loyalty maintain sales despite patent expiry
    • Lesson
    • Background
    • Impact
  • Risperdal/Risperdal Consta (risperidone) and Invega/Invega Sustenna (paliperidone): success hinges on providing significant improvement in outcome
    • Lesson
    • Background
    • Impact
  • Dovonex (calcipotriol; Leo Pharma): original product withdrawal encourages switching but damages company reputation
    • Lesson
    • Background
    • Impact
  • Zosyn (piperacillin/tazobactam; Pfizer/Taisho Pharmaceuticals): withdrawal of original formulation delays generic entry
    • Lesson
    • Background
    • Impact


  • Publications and online articles
  • Datamonitor reports and products


  • Table: Reformulation case studies summary


  • Figure: Success drivers and resistors of reformulation as a lifecycle management strategy
  • Figure: Reformulation are developed with different aims depending on the stage of the lifecycle when they are used
  • Figure: Targeting key stakeholders' needs increases chances of a successful reformulation strategy
  • Figure: Astelin/Astepro sales in the US ($m), 2011-19
  • Figure: Global sales of the Lupron franchise and Eligard ($m), 2002-16
  • Figure: Risperdal and Risperdal Consta global sales ($m), 2002-16
  • Figure: Invega and Invega Sustenna global sales ($m), 2002-16
  • Figure: Johnson & Johnson's antipsychotic franchise global sales (Risperdal, Risperdal Consta, Invega and Invega Sustenna) ($m), 2002-16
  • Figure: Dovonex US sales ($m), 2006-10
  • Figure: Zosyn sales in the US ($m), 2005-16
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