Pharma Strategy: Loss of Exclusivity (LOE) (PowerPoint PPT Slide Deck)

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This product (Pharma Strategy: Loss of Exclusivity [LOE]) is a 25-slide PPT PowerPoint presentation slide deck (PPT), which you can download immediately upon purchase.

Expiration of a drug patent means end of the branded drug value and revenue stream for a majority of pharmaceutical firms. This loss of exclusivity (LOE) puts to risk a huge amount of money in global pharmaceutical sales.

LOE certainly brings about a steep decline in a drug sales. A brand's unit share declines to about 16% by the time generics arrive and play in the market for a year. However, this is not a "game over" scenario.

This deck discusses 3 key strategies to preserve value for the brands after patent expiration:

1. Preserve Brand Equity and Patient Loyalty
2. Develop an Over-the-Counter (OTC) Version
3. Launch a Generic Version

No matter which LOE strategy a company selects to maintain product revenue, early action and execution is critical.

LOE is part of the different phases of a product's lifecycle and should be strategically thought out and managed. The presentation also highlights other avenues to tap revenue opportunities besides extending a drug's patent life through reformulations and introducing new indications.

The slide deck also includes some slide templates for you to use in your own business presentations.

The PPT provides a comprehensive guide on managing the critical phase of Loss of Exclusivity (LOE) in the pharmaceutical industry. It emphasizes the importance of early planning and execution to mitigate the impact on revenue streams. The strategies outlined are not just theoretical, but are backed by practical templates and checklists to facilitate implementation.

The presentation also delves into the nuances of brand affinity and market dynamics, offering insights into how these factors influence the choice of LOE strategy. It includes a detailed timeline for planning and executing LOE strategies, ensuring that companies can navigate this challenging phase with precision and foresight. This resource is indispensable for pharmaceutical executives aiming to sustain brand value and revenue post-patent expiry.

Source: Best Practices in Pharma Industry PowerPoint Slides: Pharma Strategy: Loss of Exclusivity (LOE) PowerPoint (PPT) Presentation Slide Deck, LearnPPT Consulting

PPT SLIDE DEEP DIVES

Strategies for Maximizing Brand Value Post-Patent

This PPT slide outlines 3 key strategies for pharmaceutical companies to maximize brand value following the loss of exclusivity (LOE) of their products. It emphasizes the importance of proactive planning in order to tap into revenue opportunities that arise when patents expire. The strategies presented are designed to extend the life cycle of branded drugs and mitigate the impact of generic competition.

The first strategy focuses on preserving brand equity and patient loyalty. This involves shifting marketing and sales efforts towards enhancing patient acquisition and retention. By prioritizing the relationship with existing patients, companies can maintain a loyal customer base even as generic alternatives become available.

The second strategy suggests developing an over-the-counter (OTC) version of the drug. This approach aims to create an OTC formulation that can help slow down the erosion of brand value after patent expiration. By offering an OTC option, firms can capture a different market segment and continue to generate revenue from a product that may otherwise face significant competition.

The third strategy involves launching a generic version of the drug. This allows companies to profit from patients who may choose to switch to a generic alternative. By entering the generic market, firms can still benefit financially while adapting to the changing landscape of drug availability.

The slide concludes with a note that these strategies have been successfully implemented by major pharmaceutical companies like Pfizer and AstraZeneca, showcasing their effectiveness in maximizing brand value post-LOE. Each strategy can be employed independently or in combination, providing flexibility in execution.

Strategies for Launching Generic Pharmaceuticals

This PPT slide outlines a strategic approach for pharmaceutical companies to effectively launch generic products in response to the increasing availability of low-cost alternatives. It presents 3 distinct methods for executing this strategy: Branded Generic, Authorized Generic, and Licensed Generic.

The Branded Generic approach focuses on utilizing existing supplies and materials to create a generic version that retains the brand identity. This method allows the company to leverage its established reputation while appealing to cost-sensitive customers.

The Authorized Generic strategy emphasizes the use of current manufacturing capabilities to produce a private-label version of the product. This approach enables firms to maintain product consistency while expanding their market reach through partnerships with private-label companies.

The Licensed Generic method involves collaborating with a competitor to develop a generic product. This partnership can facilitate an earlier market entry, which is crucial in a landscape where timing can significantly impact market share.

The slide also highlights the importance of understanding the generic landscape prior to launching a product. It suggests that timing is critical, particularly when a generic competitor has already made inroads into the market. The effectiveness of these strategies increases when the number of generic entrants is limited, ideally fewer than five.

Overall, this slide serves as a guide for executives considering the launch of generic products, emphasizing the need for strategic planning and market awareness to successfully navigate the competitive environment.

Strategic Timeline for Managing Loss of Exclusivity

This PPT slide outlines the critical importance of planning for Loss of Exclusivity (LOE) in the pharmaceutical sector, emphasizing that companies should initiate their strategies at least 2 years prior to the anticipated patent expiry date. This proactive approach allows ample time for thorough planning and execution of the chosen strategy, which is essential for maximizing product value.

The content is structured into 2 main sections. The first highlights the necessity of a two-year timeframe, warning that delaying action until the LOE date could lead to significant disadvantages. Companies that wait risk missing opportunities to optimize their product's market position and overall value. This section serves as a cautionary note, underscoring the potential repercussions of inadequate preparation.

The second section breaks down the LOE planning and execution timeline into 3 distinct phases: Pre-LOE, Peri-LOE, and Post-LOE. The Pre-LOE phase spans 2 years before the LOE date, focusing on foundational strategies. The Peri-LOE phase covers a one-year period that includes the 6 months leading up to and following the LOE date, emphasizing the need for agile responses during this transitional period. Finally, the Post-LOE phase extends for another year after the LOE, where companies can implement strategies to sustain brand value and revenue.

Overall, the slide conveys that meticulous planning is not just beneficial, but essential for effective strategy implementation. The structured timeline provides a clear roadmap for executives to follow, ensuring that they are well-prepared to navigate the complexities associated with patent expirations.

Strategic Approach to Product Lifecycle Management

This PPT slide presents an alternative strategy known as "Sunset the Brand," which is particularly relevant for firms facing the loss of exclusivity in their product offerings. This approach emphasizes a careful evaluation of expenditures and inventory management while maintaining the product's manufacturing. The goal is to minimize marketing and sales investments as demand declines.

The concept of "sunsetting" involves a strategic reduction in the number of Stock Keeping Units (SKUs) associated with a product. This reduction is not uniform across all products; rather, different items will reach their sunset phase at varying rates, necessitating a tailored approach for each. The slide underscores the importance of understanding market dynamics, which significantly influence the timing of when to initiate the sunsetting process.

Furthermore, the presence of generic competitors in the market can accelerate the need to implement this strategy. Companies must act decisively to manage their product portfolio effectively, ensuring that resources are allocated efficiently while still maintaining a market presence. This approach requires a nuanced understanding of both internal cost structures and external market conditions, making it essential for executives to stay informed and adaptable.

The insights provided here are critical for decision-makers considering how to navigate the complexities of product lifecycle management in a competitive environment. The sunsetting strategy offers a structured pathway to mitigate losses while optimizing resource allocation during challenging market transitions.

Strategic Options for LOE Based on Brand Affinity

This PPT slide presents a strategic framework for assessing Loss of Exclusivity (LOE) management in the pharmaceutical sector, focusing on the implications of brand affinity. It is divided into 2 main sections: one for high brand affinity and the other for low brand affinity, each outlining distinct strategic options.

For companies with high brand affinity, the slide emphasizes the importance of preserving and maximizing brand value while considering a switch to over-the-counter (OTC) options. A critical evaluation of whether the product meets FDA approval criteria is highlighted as essential for determining the feasibility of this switch. If the answer is affirmative, both branded and OTC strategies are warranted. Conversely, a negative response suggests a need to reinforce the existing branded strategy. The slide notes that firms unable to secure a period of exclusivity may struggle to drive OTC revenue, as market differentiation and customer loyalty can diminish if alternative treatment options are available.

On the other side, for firms with low brand affinity, the slide suggests launching a generic product or sun-setting the brand as viable strategies. It points out that a generic launch demands significant resources and emphasizes the necessity of speed to market. Securing contracts with distributors and wholesalers is deemed crucial for capturing market share. The slide advises that a generic launch is more feasible if the firm possesses internal capabilities or has established external partnerships to facilitate market access. The decision to pursue an LOE strategy, whether internally or through partnerships, should consider the firm's capabilities and the long-term potential in the generics market.

Overall, the slide serves as a decision-making tool for executives navigating the complexities of LOE strategies based on brand affinity.