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Generic Defense Strategies: Lifecycle Management Strategies to Maximize Revenue in the Face of Growing Generic Competition Product Image

Generic Defense Strategies: Lifecycle Management Strategies to Maximize Revenue in the Face of Growing Generic Competition

  • Published: May 2012
  • Region: World
  • 80 Pages
  • Scripp Business Insights

FEATURED COMPANIES

  • Lipitor
  • Plavix
  • Seroquel
  • MORE

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.

Features and benefits

- 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 XR

Highlights

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 READ MORE >

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

- Seroquel
- Lipitor
- Plavix

Format Properties
Electronic (PDF) The report will be emailed to you. The report is sent in PDF format. This is a single user license, allowing one specific user access to the product.
Enterprisewide The report will be emailed to you. The report is sent in PDF format. This is an enterprise license, allowing all employees within your organisation access to the product.
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