Sandoz launches rivaroxaban in Germany, expanding access to high-quality antithrombotic treatment options

Media Release

• With introduction of 10 mg, 15 mg and 20 mg strengths, Sandoz now provides most comprehensive range of rivaroxaban film-coated tablets available on German statutory health insurance market¹
• Rivaroxaban - 1 A Pharma^® offers high-quality, affordable alternative to reference product Xarelto^®*, with list price advantage across all three strengths²
• Launch follows successful litigation in Germany challenging dosage patent³, Sandoz plans subsequent launches in additional markets

Basel, August 28, 2025 – Sandoz (SIX: SDZ/OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today announced the launch of generic rivaroxaban in Germany, in new generic strengths of 10 mg, 15 mg and 20 mg. Rivaroxaban - 1 A Pharma^®offers patients in Germany a high-quality, affordable alternative to reference product Xarelto^®*, with a list price advantage across all three strengths.

Following successful litigation in Germany, where Sandoz was the first company to challenge the relevant dosage patent³, this launch marks a significant step in expanding access to high-quality, affordable anticoagulant therapies. Sandoz aims to introduce rivaroxaban in additional markets, supporting its Purpose of pioneering access for patients.

Thomas Weigold, Country President Germany, said: “After a 16-month delay, we can finally offer patients access to rivaroxaban in additional strengths. We are very pleased that we have successfully challenged the patent, because every day lost cost patients and the healthcare system in Germany unnecessary money.”

Rivaroxaban - 1 A Pharma^® in the 2.5 mg strength was launched in Germany in April 2024, when the main patent expired. Since then, Bayer had been able to continue selling rivaroxaban in the higher and more popular strengths of 10 mg, 15 mg and 20 mg at monopoly prices, protected by preliminary injunctions based on the dosage patent, which was revoked on July 29, 2025.

The launch of these additional strengths marks a major milestone for Sandoz in Germany, where the company now offers the most comprehensive range of rivaroxaban film-coated tablets on the statutory health insurance market¹. With this launch, Sandoz joins all open-house discount agreements for rivaroxaban in Germany, further supporting affordability and access for patients and payers.⁵

Rivaroxaban - 1 A Pharma^® is an antithrombotic agent⁴. It is used in adults for stroke prevention in non-valvular atrial fibrillation (15 mg and 20 mg strengths), treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrence. The 10 mg strength is also indicated for prevention of venous thromboembolism in adults after elective hip or knee replacement surgery. In children and adolescents, the 15 mg and 20 mg strengths are used to treat venous thromboembolism and prevent its recurrence.⁴

* Xarelto^® is a registered trademark of Bayer Intellectual Property GmbH.

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

REFERENCES

¹ Most comprehensive range of rivaroxaban film-coated tablets on the German statutory health insurance market: Lauer Taxe, as of August 15, 2025, rivaroxaban film-coated tablets from 1 A Pharma and competitors, excluding hospital and sample packs
² Lauer Taxe, as of August 15, 2025, discounts from discount agreements and imports are not included. Excluding pack sizes of 14 tablets for 15 mg and 20 mg, which are not offered for the reference product. Reference product: Xarelto^® 10 mg, 15 mg 20 mg; Xarelto^® is a registered trademark of Bayer Intellectual Property GmbH.
³ The German Federal Patent Court revoked the dosage patent (EP 1 845 961) following challenges by multiple generic manufacturers including Sandoz.
⁴ Note strength-specific differences in the areas of application, see summary of product characteristics Rivaroxaban - 1 A Pharma^® 10 mg, 15 mg, 20 mg film-coated tablets, status: September 2023
⁵ TED and ASP Monitor. Open-house contracts in accordance with Section 130a (8) SGB V; some health insurance companies have not issued any discount agreements.

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

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