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.
Features and benefits
Highlights
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
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Table of Contents
EXECUTIVE SUMMARY
Introduction
Strategic scoping and focus
Key findings
Related reports
REFORMULATION LIFECYCLE MANAGEMENT STRATEGY OVERVIEW
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
REFORMULATION CASE STUDIES
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
BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products
List of Tables
Table: Reformulation case studies summary
List of Figures
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
