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Biopharma patent cliff survival strategy: 3 critical moves

Published on 27 October 2025 Read 25 min

patent cliff agency consulting consultancy experts

The biopharma industry is approaching a critical turning point: the ‘patent cliff.’ Between 2025 and 2030, patent protection for several top-selling drugs will expire, putting billions in annual revenue at risk. Blockbuster medicines that once fueled record growth for industry giants face steep sales declines. Without a proactive strategy, the financial and operational impact could be devastating. In this article, Alcimed explores the upcoming patent expirations, the impact of the patent cliff on biopharma, and actionable strategies to offset the loss of exclusivity.

What is patent cliff?

A patent cliff is the sharp decline in revenue or profit when a company’s patent protection expires, allowing competitors to launch generic or similar products. Patents grant 20 years of exclusivity, but once they lapse, rivals can enter the market—often causing significant market share and profit losses. While the biopharmaceutical industry is most vulnerable, sectors like technology and manufacturing also face this risk.

What is a blockbuster drug?

A blockbuster drug is a highly successful medication that brings in over $1 billion in annual sales for the pharmaceutical company that markets it.

Which blockbuster drugs will expire in the next five years?

A wave of major drug patents are set to expire soon. Between 2025 and 2030, patents for nearly 200 drugs are set to expire, including approximately 70 blockbuster drugs—each generating over $1 billion in annual sales.¹²

While looking at the annual sales in 2024, notable examples of patent cliff should be mentioned here:

Keytruda (Merck, $29.5 billion): a monoclonal antibody (anti-PD-1) for treating multiple cancers including non-small cell lung cancer, melanoma, etc.
Eliquis (Bristol Myers Squibb/Pfizer, $13.3 billion): an oral anticoagulant (factor Xa inhibitor) for the prevention and treatment of thromboembolic disorders such as atrial fibrillation, deep vein thrombosis, and pulmonary embolism.
Dupixent (Sanofi/Regeneron, $14.15 billion): a monoclonal antibody (anti-IL-4Rα) for atopic dermatitis, asthma, eosinophilic esophagitis, and chronic obstructive pulmonary disease.
Opdivo (Bristol Myers Squibb, $9.3 billion): a monoclonal antibody (anti-PD-1) for various cancers including melanoma, non-small cell lung cancer, renal cell carcinoma, and others.
Gardasil/Gardasil 9 (Merck, $8.58 billion): a recombinant human papillomavirus (HPV) vaccine for the prevention of HPV-related diseases.

In addition to these top-selling drugs, several other soon-to-expire products belong to major players like AbbVie, Eli Lilly, Bayer, and AstraZeneca. It’s clear that the industry’s biggest names aren’t immune to the looming patent cliff at all.

Why the patent cliff matters?

All together, these major pharmaceuticals risk over $200 billion in annual revenue by 2030. Alcimed summed up the key impacts of patent cliff:

Revenue decline

Pharma firms experience severe revenue declines immediately after losing exclusivity. For example, Pfizer’s Lipitor’s worldwide sales plunged from $2.6 billion in Q3 2011 to $749 million in Q3 2012—a 71% drop—within one year of patent expiry.³

Increased competition

The introduction of generics and biosimilars accelerates market competition, substantially driving down prices. When Amgen launched Amjevita, a Humira biosimilar, it undercut AbbVie’s Humira’s list price by 55%. Humira’s revenue fell sharply from $21.2 billion in 2022 to $9 billion in 2024 following loss of exclusivity (LOE).⁴⁵

Innovation constraints

Pharmaceutical companies face the critical challenge of maintaining innovation while controlling costs amidst shrinking R&D budgets. Following looming patent cliffs and new pricing legislation, major firms such as Pfizer, Bristol-Myers Squibb, Bayer and Novartis executed across-the-board R&D cutbacks and layoffs, signaling constrained investment in novel drug discovery.⁶

3 strategies for offsetting the LOE of patient cliff in biopharma

The critical turning point is on its way. Biopharma firms have deployed and should deploy multifaceted strategies to safeguard revenue streams and protect market position despite inevitable LOE.

Strategy 1: lifecycle extensions & evergreening

Companies can extend their market exclusivity and protect their revenues by securing additional patents through strategies like patent term extensions, reformulating existing drugs and repurposing (identifying and validating new therapeutic uses for existing biologically active substances—including already approved drugs). Besides, introducing new delivery methods—a practice commonly referred to as evergreening—is also implemented to offset the LOE. Merck has developed the subcutaneous Keytruda and just won FDA’s approval for KEYTRUDA QLEX™ across most solid tumor indications for KEYTRUDA in September, 2025.⁷ This win will helps defend market share given the coming LOE for Keytruda.

Strategy 2: mergers and acquisitions

Big pharmas typically adopt a multipronged strategy to mitigate the impact of the patent cliff, where mergers and acquisitions (M&A) are actively implemented alongside other core strategies. For example, Pfizer’s acquisition of oncology specialist Seagen targets a pipeline with strong growth prospects (projected ~$3B in sales by 2027), while complementing its AI-driven R&D efforts and cost-saving goals.⁸ Bristol Myers Squibb’s $74B purchase of Celgene was a proactive step to counter the impending patent cliff of its key drugs Yervoy and Eliquis through high-value innovative medicines and leading scientific capabilities.⁹ Additionally, Merck’s $10 billion acquisition of Verona Pharma in July 2025 acts as a strategic safeguard, offsetting revenue losses from Keytruda’s patent cliff by leveraging Verona’s high-potential assets.¹⁰

Strategy 3: brand defense & pricing strategy

With LOE approaching, companies often switch promotional strategies—reducing salesforce while leveraging loyalty programs, real-world evidence, and value-based pricing. Examples include: AstraZeneca’s Nexium, which redeployed reps 2–3 years pre‑LOE.¹¹ AbbVie, redeploying Humira reps onto Skyrizi and Rinvoq two years before their patent expired.¹²

The looming patent cliff threatens massive revenue declines in pharma, especially as blockbusters lose exclusivity. Firms must act now to safeguard innovation and market access and mobilize early to preserve revenue streams and R&D momentum. Alcimed stands ready to accompany every player concerned by this turning point. Let’s co-create the future together, don’t hesitate to contact our team.

About the author,

Chaoyue, Senior Consultant Lead in Alcimed’s Life Sciences team in France

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