Navigating the GLP-1 Gauntlet: Novo Nordisk's Legal and Competitive Challenges in the Obesity Drug Market

The GLP-1 obesity drug market has become a battleground for pharmaceutical giants, with Novo Nordisk (NVO) at the center of a storm of legal disputes, patent battles, and rising competition. As the market's dominant player, Novo's ability to maintain its leadership hinges on its capacity to navigate these challenges while innovating in a rapidly evolving landscape. This article examines the company's legal and competitive struggles, evaluates its long-term viability, and offers insights for investors.

Legal Challenges: Patent Disputes and Public Health Risks

Novo Nordisk has aggressively defended its intellectual property, filing over 130 lawsuits in 2025 to combat unapproved compounded versions of semaglutide-based drugs. These lawsuits target pharmacies and telehealth companies that market unsafe alternatives, often sourced from unregulated suppliers in China. The company has secured 44 permanent injunctions, but its legal strategy faced a setback in July 2025 when a Delaware court ruled that Viatris (a Mylan subsidiary) did not infringe on a key patent covering semaglutide monotherapy. This decision narrowed Novo's patent protection and forced a recalibration of its IP strategy.

The company's reliance on a sprawling patent portfolio—320 U.S. applications and 154 granted patents—has drawn scrutiny. Critics argue that follow-on patents for minor modifications (e.g., delivery devices) extend exclusivity until 2042, stifling generic competition. Meanwhile, the FDA's crackdown on compounded GLP-1 drugs in 2025 came too late to prevent market saturation by off-brand alternatives, which now serve over 1 million U.S. patients. This erosion of trust and market share has pressured Novo to revise its 2025 revenue growth forecast downward to 8–14%.

Competitive Landscape: Rivals Redefining the Market

Novo's dominance is under siege from a constellation of competitors, led by Eli Lilly (LLY), whose Zepbound and Mounjaro have captured significant market share. Zepbound, in particular, has driven a 140% quarterly sales growth for Lilly in Q2 2024, outpacing Novo's Wegovy. Lilly's $27 billion investment in obesity and diabetes therapies, including the next-gen Orforglipron, underscores its aggressive expansion.

Other contenders are also gaining traction:
- Amgen (AMGN) is developing MariTide, a once-monthly GLP-1 drug showing 14.5% weight loss in trials.
- Roche (RHHBY) acquired Carmot Therapeutics to fast-track CT-996, an oral GLP-1 agonist.
- Pfizer (PFE) is advancing Danuglipron, an oral GLP-1 drug, while Sanofi and emerging biotechs like Structure Therapeutics and Viking Therapeutics are innovating with dual-agonist and oral formulations.

These innovations—oral delivery, longer dosing intervals, and multi-pathway therapies—are redefining patient expectations and forcing Novo to accelerate its pipeline. While Novo's CagriSema (semaglutide + amylin analogue) achieved 15.7% weight loss in trials, falling short of the 25% benchmark, its oral semaglutide and Amycretin (a unimolecular GLP-1/amylin agonist) remain key bets.

Financial Projections and Market Share Dynamics

Novo's 2025 revenue projections have been scaled back due to compounded GLP-1 competition and pipeline delays. Evaluate Pharma forecasts Eli Lilly to surpass Novo in market share by 2030, with Zepbound and Mounjaro projected to generate $25.5 billion and $36 billion in sales, respectively. Amgen's MariTide is expected to capture $3.7 billion, while Roche's CT-388 could add $18.8% weight loss in trials.

Novo's R&D spending has surged to $7.17 billion in 2024, a 43.57% increase from 2023, but its financialization model—prioritizing shareholder returns over R&D—has drawn criticism. From 2020 to 2024, the company spent 41% more on buybacks and dividends than on R&D, a trend that risks stifling long-term innovation. Meanwhile, manufacturing challenges, including a $16.5 billion acquisition of Catalent's facilities, have added a mid-single-digit drag on operating profits.

Investment Outlook: Balancing Risks and Opportunities

For investors, Novo Nordisk's long-term viability depends on its ability to:
1. Accelerate pipeline approvals: The success of CagriSema's revised Phase III trial (REDEFINE-11) and Amycretin's Phase III trials in 2026 will be critical.
2. Navigate regulatory scrutiny: The FDA's evolving stance on patent eligibility and compounded drugs could limit Novo's exclusivity.
3. Address supply chain and pricing pressures: Partnerships like the $812 million alliance with Deep Apple Therapeutics and collaborations with CVS Health aim to improve access but face logistical hurdles.

While Novo remains a leader in GLP-1 therapies, its market share is being eroded by faster-moving rivals. Investors should monitor key metrics:
- CagriSema's REDEFINE-4 trial results (2025).
- Amycretin's Phase III progress (2026).
- Competitor launches of oral and dual-agonist therapies.

Conclusion: A Tenuous Crown

Novo Nordisk's position in the GLP-1 obesity drug market is both formidable and fragile. Its legal and patent strategies have delayed generic competition but drawn regulatory and public scrutiny. Meanwhile, rivals like Eli Lilly and Amgen are outpacing Novo with next-gen therapies and aggressive pricing. For investors, the company's long-term success will hinge on its ability to innovate, adapt to regulatory shifts, and maintain patient trust in an increasingly crowded market. While Novo's pipeline and manufacturing scale offer upside, the risks of patent expiration, supply chain bottlenecks, and competitive erosion cannot be ignored. A cautious, long-term investment approach—focusing on pipeline milestones and regulatory developments—is advisable for those considering exposure to this high-stakes sector.