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Research and Markets: Generic Defense Strategies: Lifecycle Management Strategies to Maximize Revenue in the Face of Growing Generic Competition.

DUBLIN -- Research and Markets ( has announced the addition of the "Generic Defense Strategies: Lifecycle Management Strategies to Maximize Revenue in the Face of Growing Generic Competition" report to their offering.

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


- 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

Key Topics Covered:


- Current challenges facing pharma

- Developmental lifecycle management strategies

- Commercial lifecycle management strategies

- Legal lifecycle management strategies

- Case studies

Current Challenges Facing Pharma

- 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

- 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

- Strategic pricing

- Brand loyalty and compliance programs

- Rx-to-OTC switches

- Authorized generics

- Pay-for-delay

Legal Lifecycle Management Strategies

- 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

- 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




Companies Mentioned

- Seroquel

- Lipitor

- Plavix

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Publication:Business Wire
Date:Jun 19, 2012
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