This blog is part of an ongoing series, A Brave New World: Finding life sciences success in modern markets.

As the life sciences industry braces for the most formidable wave of Loss of Exclusivity (LOE) in more than a decade, dubbed Patent Cliff 2.0, pharma executives are under pressure to do more than just brace for impact. Patent losses at estimated net manufacturer prices are set to exceed $90B between 2025-2029, more than in either of the last two 5-year periods. With a mix of both small and large molecules that will see generic and biosimilar competition, these products are in many of life sciences’ largest therapeutic areas. Market fluctuations will be widely felt.

Source: IQVIA Institute Understanding the Use of Medicines in 2025

The next decade in life sciences will be a Brave New World. The product lifecycle is facing economic compression from launch to LOE due to the confluence of market dynamics, price erosion, and public policy. Addressing the new lifecycle rules for the next 10 years requires a broad rethink of the last two decades. When it comes to LOE, extending the area under the economic lifecycle curve takes on added importance because of the compression that is occurring earlier and elsewhere in a portfolio.

There are many variations for post LOE performance. Brand strategy and market dynamics both play a role in how fast and how deeply volume, share, and economics erode. LOE dynamics requires a broad look across many dimensions and markets to identify the appropriate curve or curves that match situational uniqueness and manufacturer strategy.

Source: IQVIA Commercial Analytics Library; LAAD Rx and Mx.

The upcoming patent cliff is steeper, more complex, and requires a more advanced “next generation” playbook than years past. However, as the industry has seen in past LOE battles, brands can retain meaningful value post-LOE if leaders act with foresight, discipline, and precision.

1. Patent Cliff 2.0 is different and BIGGER

The last patent cliff was dominated by small molecules. This one encompasses multiple biologics, including complex therapies with unique delivery systems, administration pathways, and stability concerns.

Biologics don’t follow the same LOE rules. Biosimilar uptake is slower than generics due to market inertia, switching hesitancy, regulatory nuances, and channel dynamics. However, price pressure is just as real and sometimes worse.

Source: IQVIA Analysis

As one of the most recent case studies, AbbVie’s Humira maintained brand share post-LOE but lost 60% of net sales due to steep discounting.

Source: IQVIA Net Sales Library; IQVIA Estimates, methodology, and analysis

Bottom line: LOE strategy today requires more nuance, earlier action, and stronger cross-functional coordination than ever before. Volume can be defended with strong execution.

2. Tailor strategy to your product’s LOE archetype

There is no “one-size-fits-all” approach to LOE. Proactive teams categorize their brands into LOE archetypes to guide decisions:

• Is the drug a small molecule or a complex biologic? How many competitors are expected and when?
• Is the drug administered by a healthcare provider, by a specialty pharmacy, or through retail?
• Does the drug have unique features, such as a delivery mechanism, a narrow therapeutic window, or manufacturing complexity?
• What are the payer economics, quality/cost of market access, and 340B utilization in context to key geographies?

For example:

• A CNS product with patient stability concerns may see slow erosion.
• A pill for hypertension may be substituted automatically within weeks.
• A buy-and-bill oncology infusion administered drug might retain share longer than a retail drug or in hospitals systems with 340B discounts.
• Complex drug formulations can increase physician and patient loyalty.
• Highly discounted drugs with spread economics may retain share for longer.

Mapping LOE archetype enables smart forecasting, prioritization, and tactical selection. With thousands of analogs to choose from, getting the archetype right is a key strategy.

3. Start early, stay focused

The best-in-class LOE plan begins early. Many brands wait until 2 years out to begin planning for LOE, which is often too late for meaningful strategies to be effective. Clinical strategies can take a decade to plan, while evidence strategies can take years to play out. Even contracting, promotion, and sales strategies need to initiate at least 4–5 years before expiry. This gives time to:

• Develop lifecycle extensions or new formulations (e.g., subcutaneous instead of intravenous).
• Align patient support and contracting strategies.
• Run analog modeling to project erosion curves.
• Build cross-functional alignment with brand, access, legal, and supply chain.
• Create scenario modeling for various investment cases.

In the post-Inflation Reduction Act world, Maximum Fair Price (MFP) negotiations also must be accounted for. While MFP negotiations may not equate to a patent loss, many of the same drivers of LOE are present. The need to substantiate value utilizing evidence, to plan indication strategies thoughtfully, and to account for the implications of lifetime pricing strategies are all important.

Late planning = fewer options. Early planning = strategic breathing room.

4. Build a multi-front defense

To preserve value, the best teams act across multiple critical fronts:

Patients & Prescribers:

• Copay cards, vouchers, and direct-to-patient discount programs keep patients loyal by eliminating cost barriers and capitalizing on a patient’s willingness to come out of pocket for branded products.
• Dispense-as-Written (DAW) campaigns can protect clinical continuity in sensitive areas (e.g., epilepsy, schizophrenia). Know state-specific substitution policies and the impact on branded and generic utilization.
• Educate prescribers on the brand’s track record and differences that may matter.

Payers:

• "Brand-for-generic" contracting uses deep rebates in exchange for formulary status to retain volume. With multiple analogs of brands who found success with this strategy, there is clear room and willingness in the market for branded manufacturers to utilize it.
• Authorized Generics (AGs): Launching your own generic protects share and controls erosion but comes with its own complexities. Understanding how generic distribution and contracting work is different than having experience in the branded world.
• Let go strategically: Let your contracts work for you and apply sales effort where net value and brand loyalty are highest.

In a case study of a successful LOE strategy, Brand Z utilized both authorized generic and brand-for-generic contracting strategies. Despite having multiple generics in the market, the LOE strategies preserved share for the manufacturer for more than a year at the brand and plan level.

• Contract wholesalers and retail chains to favor your AG or brand.
• Hospital partnerships: Offer support, rebates, or training that generics don’t.
• Leverage wraparound services: Digital tools, adherence support, and Real-World Evidence differentiate your brand in payer, system, and provider discussions.

5. Innovate where it matters

You can’t stop the clock, but you can reset part of the franchise:

• Develop new formulations, delivery devices, or combinations.
• Utilize the strength of a portfolio to create innovative contracting.
• Provide data or services that generics can’t match.
• Identify if there is a direct-to-consumer strategy to offer discounted prices to the market.

Many next generation strategies are finding market traction as consumers become closer to the brands they are utilizing. The rise in the use of cash, cash discount cards, and direct to patient distribution models represent new avenues for exploration. Particularly for brands that have high levels of patient or physician loyalty, building avenues to maintain access to the brand can significantly shift the area under the economic lifecycle curve.

6. Don't just defend volume, defend value

In the LOE zone, not all volume is worth chasing. Know your margins by channel and geography. Focus effort where:

• The brand can still win while maintaining net prices.
• Physician, system, and patient loyalty are high.
• Economics work to sustain promotional investment.

Focus effort to strategic segments. Preserving value is not just about preserving net sales. It is also about finding investment for future research and development. In one case study for a large late-in-lifecycle retail brand, negative margins for a segment of healthcare providers eroded the net value of nearly half of all targeted prescribers. By shifting effort, the manufacturer was able to redeploy valuable resources to other longer-term growth strategies.

The role of personal and non-personal promotion is also an important variable as products near their LOE. Many manufacturers will use a Contract Sales Organization (CSO) and consider risk sharing agreements with third parties to offset their potential costs. However, modeling slower erosion and how to make go/no-go decisions in this situation is challenging even for the most experienced manufacturers.

At the same time, the cost of digital promotion or a remote sales organization can reduce the cost of promotion while maintaining a share of voice in front of customers. Potential solutions are not binary.

7. Track, tune, and adapt in real time

The best strategies evolve. Set up an LOE “situation room” to:

• Monitor market activity (competitor entries, pricing, uptake).
• Measure tactic-level impact with purpose-built analytics.
• Pivot quickly when you experience success or failure.
• Create real-time alignment on strategic options before they play out to accelerate your decision making.

Leverage historical analogs to forecast, benchmark, and adjust as events unfold. Broadly study LOE brand, physician, system, and patient behaviors to expand your understanding of what works and what does not. Don’t just execute; rather, learn and optimize as you go.

Executive Takeaways:

• Start early. LOE planning should begin years ahead of expiry.
• Customize the playbook. Archetype your brand and corresponding market dynamics, then plan accordingly.
• Act across four fronts. Patients, prescribers, payers, and pharmacy distribution channels must all be addressed simultaneously.
• Sacrifice strategically. Use deep discounts and AGs to defend where it pays off. Know your discount tolerance, where your value is best, and be prepared to walk away.
• Innovate pre-LOE. Differentiate your brand with new formulations, services, or combinations.
• Use data to steer. Real-time insights, analog benchmarks, and scenario modeling are your edge.
• Know next gen strategies. Value-based targeting, tapping into patient and physician loyalty, and micro-targeting promotional effort can yield outsize impact late in the brand lifecycle.

LOE is not the end. It's the next chapter in brand lifecycle management, and a litmus test for commercial excellence. The economic compression that is happening across the lifecycle is creating pressures industry-wide. Working through LOE options in modern markets requires new approaches.

With a clear archetype strategy, the right set of tactical levers, and disciplined execution, pharma leaders can turn a patent cliff into a controlled ride into the sunset.