Bayer AG announced that the U.S. Patent and Trademark Office has granted a Patent Term Extension for rivaroxaban. Rivaroxaban is the active pharmaceutical ingredient of Xarelto®. Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc.

The patent protection for the active ingredient in the U.S. now runs until August 28, 2024.

The U.S. FDA has been informed about the changed patent expiration date as a result of the extension for more than 3.7 years and updated the patent information for Xarelto® in the Orange Book.

About Xarelto® (Rivaroxaban): Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) and is marketed under the brand name Xarelto®. Xarelto is approved for seven indications, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other NOAC:

• The Prevention of stroke and systemic embolism in Adult Patients with non-valvular atrial fibrillation (AF) with one or more risk factors

• The treatment of deep vein thrombosis (DVT) in adults

• The treatment of pulmonary embolism (PE) in adults

• The prevention of recurrent DVT and PE in adults

• The prevention of venous thromboembolism (VTE) in adult Patients Undergoing Elective hip replacement surgery

• The prevention of VTE in Adult Patients Undergoing elective knee replacement surgery

• The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack (TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine