Generic Defense Strategies

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Generic Defense Strategies
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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. Provides an 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. Reviews different developmental, commercial and legal lifecycle management strategies available to pharma to protect their franchises against generics. Analyzes the pros and cons of lifecycle management strategies, supported by case study analysis. In depth case study analysis of the numerous lifecycle management strategies used to protect Lipitor, Plavix and Seroquel XRLifecycle 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. 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?

About the author
Disclaimer
EXECUTIVE SUMMARY
-- Current challenges facing pharma
-- Developmental lifecycle management strategies
-- Commercial lifecycle management strategies
-- Legal lifecycle management strategies
-- Case studies
Current Challenges Facing Pharma
-- Summary
-- Declining innovation increases the necessity for generic defense
- Falling productivity and growing costs hamper pharma's R&D
-- The patent cliff represents a major resistor to branded pharma growth
- Branded pharma set to lose $82bn due to the patent cliff
-- How to counter the impact of generics
- Developmental lifecycle management strategies
- Commercial lifecycle management strategies
- Legal and regulatory strategies
Developmental Lifecycle Management Strategies
-- Summary
-- Introduction
-- Next generation products
- Timing of second generation product launches is crucial
-- Modified APIs
- Salt switches
- Ester switches
-- Reformulations
- Modified release formulations
- New routes of delivery
-- Fixed dose combinations
Commercial Lifecycle Management Strategies
-- Summary
-- Introduction
-- Strategic pricing
-- Brand loyalty and compliance programs
-- Rx-to-OTC switches
-- Authorized generics
-- Pay-for-delay
Legal Lifecycle Management Strategies
-- Summary
-- Introduction
-- Enhancing exclusivity periods
- Exclusivity (data and marketing)
- Patent term extension
- Pediatric extensions
- Exceptions related to orphan drugs
-- Defensive patenting
- Product derivatives
- Formulation patents
- Process patents
-- Patent litigation
- EU specific
- US specific
Case studies
-- Summary
-- Introduction
-- Seroquel
- Seroquel patent terms and exclusivity extensions
- Seroquel XR
-- Lipitor
- Fixed dose combination formulations containing Lipitor
- Lipitor's product derivative patents
- Lipitor patent term and exclusivity extensions
- Impact of generic atorvastatin on Lipitor in the US
- Impact of generic atorvastatin on Lipitor in the US
-- Plavix
- Plavix product derivatives patents
- Plavix patent terms and exclusivity extensions
- Plavix formulations
- Impact of generic clopidogrel on Plavix in the US and Europe
Appendix.
-- Methodology
- Secondary research
-- Glossary/Abbreviations
-- Bibliography/References

TABLES
Table: AstraZeneca's litigation over quetiapine ANDA filers.

FIGURES
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

Companies mentioned

Devoteam SA, First Aviation Services Inc., First Data Corporation, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Informa plc, Janssen Pharmaceuticals, Inc., Schindler Holding Ltd.

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