Sandoz's Strategic Expansion in Generic Anticoagulants and Its Implications for Biosimilars Growth

In the ever-evolving pharmaceutical landscape, companies that master the art of navigating patent thickets and regulatory hurdles often emerge as market leaders. Sandoz, a subsidiary of Novartis, has demonstrated this mastery with its aggressive expansion into generic anticoagulants and biosimilars. By leveraging strategic legal victories and regulatory approvals, Sandoz is not only capturing high-margin markets but also redefining the competitive dynamics in the $300 billion biosimilars sector. For investors, this represents a compelling case study in how legal acumen and operational execution can drive long-term value creation.

Patent Challenges as a Strategic Weapon

Sandoz's recent triumphs in the European rivaroxaban (Xarelto) market exemplify its ability to turn legal battles into commercial wins. In Germany, the company successfully challenged Bayer's key dosage patent (EP 1 845 961) in 2025, leading to the revocation of the patent and the launch of its generic rivaroxaban in 10 mg, 15 mg, and 20 mg strengths. These higher-strength formulations, previously monopolized by Bayer, now offer Sandoz a significant market edge. The 16-month delay caused by preliminary injunctions was a temporary setback, but the eventual victory unlocked access to a broader patient population and positioned Sandoz as a cost-effective alternative.

This legal strategy is not isolated. Sandoz has similarly challenged patents for denosumab (Prolia/Xgeva) and etanercept (Enbrel), signaling a consistent playbook: identify blockbuster drugs nearing patent expiry, secure regulatory approvals for biosimilars, and then litigate to remove remaining barriers. The result? A portfolio of high-margin products that capitalize on the post-patent erosion window, where pricing power remains strong before generic competition fully saturates the market.

Regulatory Approvals and Market Access

Regulatory approvals have further amplified Sandoz's momentum. In the U.S., the FDA approved its denosumab biosimilars (Wyost and Jubbonti) in March 2024, with a planned launch in May 2025 under a settlement with Amgen. This move taps into the $10 billion denosumab market, where Sandoz's interchangeable biosimilars can capture market share through price competition. Meanwhile, in Europe, Sandoz's rivaroxaban generic has already secured a dominant position in Germany, with plans to expand to other markets where patent challenges are ongoing.

The company's ability to secure regulatory approvals quickly is a testament to its infrastructure. Sandoz's new production centers in Slovenia and its proposed acquisition of Just-Evotec Biologics in France underscore its commitment to scaling manufacturing capacity. These investments not only reduce reliance on third-party suppliers but also ensure rapid scalability for new product launches—a critical advantage in markets where first-mover status often dictates long-term profitability.

Financial Performance and Biosimilars Growth

The financial implications of Sandoz's strategy are equally impressive. In H1 2025, biosimilars accounted for 29% of Sandoz's total net sales, up from 27% in H1 2024. Net sales for the segment reached $1.496 billion, reflecting a 12% growth at constant currencies and 17% at comparable growth rate (CGR). This outperformance is driven by a mix of product launches (e.g., Pyzchiva, Tyruko) and favorable pricing dynamics in markets like Germany, where open-house discount agreements further compress costs for payers.

The company's core EBITDA margin expanded to 20.0% in H1 2025, up 2.5 percentage points year-over-year, highlighting the profitability of its biosimilars business. With 27 assets in development targeting $200 billion in originator sales, Sandoz is well-positioned to sustain this growth trajectory. The anticoagulant market alone, projected to grow at a 9.11% CAGR to $81.16 billion by 2034, offers a fertile ground for expansion, particularly as Sandoz's generic rivaroxaban gains traction in Europe.

Investment Implications

For investors, Sandoz's dual focus on legal innovation and regulatory execution presents a unique opportunity. The company's ability to navigate complex patent landscapes—while simultaneously scaling its biosimilars portfolio—positions it as a top-tier player in a sector where margins are often eroded by price competition. Unlike traditional generic manufacturers, Sandoz's biosimilars business offers higher margins due to the complexity of biologics and the limited number of competitors in key therapeutic areas.

Moreover, Sandoz's strategic acquisitions and manufacturing expansions suggest a long-term vision that aligns with the growing demand for affordable biologics. As healthcare systems worldwide prioritize cost containment, the company's ability to deliver high-quality, low-cost alternatives will become increasingly valuable.

Conclusion

Sandoz's strategic expansion in generic anticoagulants and biosimilars is a masterclass in leveraging legal and regulatory tools to capture high-margin markets. By turning patent challenges into commercial wins and securing regulatory approvals for blockbuster biosimilars, the company has positioned itself as a leader in a sector poised for sustained growth. For investors, this represents a compelling case for long-term investment, particularly as Sandoz continues to execute on its pipeline and expand its global footprint. In an industry where innovation often comes at the cost of profitability, Sandoz has found a formula that balances both—making it a standout in the evolving pharmaceutical landscape.