Generics Defense Strategies

Overview of key challenges facing pharma in terms of R&D and the patent cliff, highlighting why LCM is more crucial than ever for pharma.


Dallas, TX -- (ReleaseWire) -- 05/16/2012 -- Over the next 5 years, branded pharmaceutical manufacturers face a period of intense generic competition as numerous branded blockbusters face patent expiry. Consequently, having a clear idea about how to maximize portfolio sales and defend against generic competitors is one of the most critical considerations when considering lifecycle management (LCM) strategies.


Lifecycle management should not be left until only few years are left to patent expiry. Revenues can be maximized during launch and peak phases by employing the right approaches. If a company starts planning its lifecycle management strategy early, it has more strategies available. However, many companies leave planning until late in the lifecycle.

While each aspect of lifecycle management is best considered independently, the most effective generic defense strategies tend to marry multiple strands together, highlighting the desirability of developing an integrated approach to lifecycle management.

Developmental lifecycle management can boost revenues both in the mid and late stages of a drug’s lifecycle and are a preferred option so long as the likelihood of their success is high, depending on product characteristics and market environment.

Your key questions answered

- Why is generic defense so important to pharma now?
- What different generic defense strategies are available to pharma?
- Why have certain LCM strategies been successful whereas others have failed?

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List Of Figures available in this report:

Figure: Pharma R&D challenges and solutions
Figure: Despite growth in R&D spend, productivity continues to decline, 1990–2009
Figure: Impact of generics on branded pharma
Figure: Branded sales decline for the top 50 pharma companies due to the expiry of brands in the US, Japan, and five major EU markets, 2010–14
Figure: Tactics available to pharma to both grow and protect branded drug sales
Figure: Developmental lifecycle management strategies can boost sales in both mid and late stages of the lifecycle
Figure: Successful franchise defense with second generation product – Losec to Nexium
Figure: Sustaining value by successive formulation enhancements:
Figure: Using fixed dose combinations to aid generic defense:
Figure: Commercial lifecycle management strategies tend to have the greatest impact post-patent expiry
Figure: Legal and regulatory strategies tend to extend the protected life of a drug
Figure: Enhancing exclusivity periods in the US
Figure: Enhancing exclusivity periods in the EU
Figure: Time line of Paragraph IV ANDA filings that are challenged
Figure: Quarterly revenues of Seroquel franchise 2010–11
Figure: AstraZeneca’s success in switching patients to Seroquel XR by region
Figure: Quarterly US sales of Lipitor 2009–11
Figure: Quarterly EU sales of Lipitor 2009–11
Figure: The short lived impact of generic clopidogrel on US sales of Plavix
Figure: Quarterly EU sales of Plavix 2008–11

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