Patent Pressures in Pharma: Novo Nordisk’s GLP-1 Struggles and the Coming Patent Cliff

By Eminent Global Research Solutions

Introduction: A Blockbuster Under Siege

Few drugs in recent memory have captured global attention like Novo Nordisk’s GLP-1 agonists, best known by their brand names Ozempic and Wegovy. Marketed for type 2 diabetes and obesity, these medicines generated billions in revenue and transformed Novo Nordisk into Europe’s most valuable company by market capitalization.

But beneath the financial triumph lies an urgent intellectual property (IP) challenge. Patent lapses, decentralized compounding, and global legal inconsistencies are eroding Novo Nordisk’s exclusivity and threatening its grip on a market expected to exceed $100 billion by 2030.

Novo’s struggles are not unique. They are the leading edge of a looming “patent cliff” — a tidal wave of expirations that could strip the world’s largest pharmaceutical companies of an estimated $180 billion in annual sales between 2027 and 2028.

This feature explores Novo Nordisk’s GLP-1 patent enforcement battles, connects them to the broader patent cliff crisis, and considers how the pharmaceutical sector is adapting to protect innovation, ensure patient access, and safeguard commercial lifelines.

Novo Nordisk and the GLP-1 Patent Puzzle

The Shortage Loophole

The surge in demand for GLP-1 drugs left Novo Nordisk scrambling to meet supply. U.S. compounding pharmacies — legally permitted to make copies of drugs during shortages — stepped in to fill the gap.

This was meant as a temporary fix, but even after supply constraints eased, many compounders continued manufacturing and selling GLP-1 formulations, often at lower prices. Novo Nordisk suddenly faced a parallel market that undermined both its IP rights and pricing power.

The Canadian Setback

The challenges extended beyond U.S. borders. In Canada, a critical GLP-1 patent was not properly renewed, exposing Novo Nordisk to potential generic competition by 2026 — years earlier than anticipated.

This lapse highlights the risks of managing sprawling global patent portfolios, where administrative oversight can translate into billions lost.

Litigation and Enforcement

Novo Nordisk has filed lawsuits against compounding pharmacies in the U.S., but enforcement is complicated. Courts must weigh the balance between protecting IP and maintaining patient access to life-saving treatments.

In the public eye, Novo risks appearing more concerned with profits than patients. For the industry, the case underscores the fragility of exclusivity in an era of rising demand and shifting legal frameworks.

The Broader Crisis: Pharma’s Patent Cliff

While Novo’s GLP-1 battles are unfolding in real time, a broader industry storm looms. Between 2027 and 2028, patents on some of the world’s best-selling drugs — from oncology to immunology — will expire, slashing protected revenues.

Key Drugs Approaching Expiry

• Merck’s Keytruda (oncology): $25 billion annual revenue at risk.

• Bristol Myers Squibb’s Eliquis (anticoagulant): $12 billion annual revenue.

• AbbVie’s Skyrizi & Rinvoq (immunology): billions in sales facing biosimilar pressure.

The cliff could reshape the competitive landscape, as generics and biosimilars enter markets and force price erosion.

The Numbers at Stake

Analysts estimate nearly $180 billion in annual pharma sales could vanish, marking one of the largest single shifts in the industry’s modern history. For comparison, that figure is larger than the GDP of many mid-sized nations.

Industry Playbook: Strategies for Survival

Patent Thickets and Extensions

Pharma companies have long relied on patent thickets — overlapping IP filings on formulations, delivery methods, or secondary uses — to extend exclusivity. But regulators in the U.S. and Europe are increasingly scrutinizing these strategies, framing them as anti-competitive.

Mergers and Acquisitions (M&A)

With pipelines under pressure, companies are turning to M&A. For instance, Merck has pursued deals worth over $10 billion to refill its oncology pipeline ahead of Keytruda’s expiry. Such acquisitions are both a hedge against revenue loss and a bet on early-stage innovation.

Licensing and Partnerships

Licensing agreements are becoming more creative, with royalties tied to drug pricing negotiations and flexible cross-border terms. This approach helps balance the need for revenue with patient access in cost-sensitive markets.

The Role of AI and Data

As R&D shifts toward AI-assisted drug discovery, new IP questions emerge: Who owns AI-generated molecules? How should licensing handle algorithmic innovation? Pharma firms are embedding AI clauses into contracts to clarify ownership and usage rights.

Regulatory and Cross-Border Dimensions

FDA Loopholes in the U.S.

The compounding exemption that hurt Novo Nordisk may become a recurring flashpoint. Regulators face the delicate task of ensuring drug availability without creating permanent backdoors into exclusivity.

Global Patent Management Risks

The Canadian lapse serves as a cautionary tale: missed deadlines or local procedural errors can have outsized consequences. Multinational pharma must adopt stronger global IP governance frameworks.

The Rise of China

China is now outpacing the U.S. in clinical trials and licensing deals. By 2025, over 37% of new molecules licensed by global pharma are expected to originate from China. This shift forces Western companies to rethink IP strategies in markets with different enforcement norms.

Expert Insights: Lessons for IP and Life Sciences

• Balance of Access vs. Exclusivity: Novo’s case illustrates the reputational risks of strict enforcement. Patient advocacy will increasingly shape how courts and regulators view IP disputes.

• Beyond Patents: Companies must invest in data exclusivity, trade secrets, and regulatory protections as complementary shields.

• Diversification: Relying on a single blockbuster is increasingly risky. Pharma must spread bets across therapeutic areas, platforms, and geographies.

Future Outlook: What Lies Beyond the Cliff

The coming decade will redefine pharma’s IP strategy. We are likely to see:

• Hybrid protection models blending patents with digital/data rights.

• Accelerated adoption of AI-driven R&D, reshaping ownership norms.

• Greater collaboration between pharma and regulators to balance innovation incentives with affordability.

• Global treaties and harmonization efforts, especially around genetic resources and AI.

Novo Nordisk’s GLP-1 battle is not just a company story — it is a microcosm of the industry’s IP future.

Conclusion: Innovation at a Crossroads

The pharmaceutical industry stands at a critical juncture. The erosion of Novo Nordisk’s GLP-1 exclusivity shows how fragile patents can be in the face of demand shocks, legal loopholes, and cross-border complexities. At the same time, the looming patent cliff threatens to dismantle billions in protected revenues across the sector.

For pharma, the message is clear: traditional IP strategies are no longer enough. Survival will depend on innovative licensing, robust global governance, AI integration, and proactive regulatory engagement.

For patients, the stakes are equally high — the balance between affordable access and sustainable innovation will define the next era of medicine.

About Eminent Global Research Solutions

At Eminent Global Research Solutions, we provide specialized IP research, patent analysis, and strategic insights tailored to the life sciences and healthcare sectors. From patent monitoring to infringement analysis, our team helps organizations navigate the complexities of innovation protection in a rapidly evolving global marketplace.