FDA Approves First Generics of Rivaroxaban Tablets

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FDA’s Center for Drug Evaluation and Research (CDER) Division of Drug Information said on March 10, 2025 that FDA has approved the first generics of rivaroxaban, in tablet form, to reduce risk of major cardiovascular events in adult patients with coronary artery disease, as well as major thrombotic vascular events in adults with peripheral artery disease (PAD), including those who recently underwent a lower extremity revascularization procedure due to symptomatic PAD (1).

Rivaroxaban is more commonly known by its brand name, Xarelto, manufactured by Johnson & Johnson Innovative Medicine, formerly Janssen Pharmaceuticals. It is an anticoagulant, the likes of which are among the most commonly prescribed medications in the United States, according to CDER (1).

In a press release, CDER said FDA’s Drug Competition Action Plan aims to address, among other objectives, both the challenges of developing generics and promoting more generic competition (1). The agency further said that first generics are a public health priority, and that it prioritizes reviews of applications for such products. In rivaroxaban’s case, CDER said the risk of major cardiovascular events—such as heart attack or stroke related to blood clots forming in the body, and traveling to the brain—is a serious concern, and that approval of the first generics for the drug will provide more treatment options to Americans reliant on anticoagulants.

Rivaroxaban has long been an option on the market to reduce risk of cardiovascular events such as stroke and blood clots. In October 2014, Janssen recalled 13,500 bottles of Xarelto following a customer complaint of a microbial contaminant in a sales sample (2). The affected lots were traced to a facility in Gurabo, Puerto Rico, according to FDA at the time.

A generic form of rivaroxaban, Rivaroxaban Accord, was recommended for market authorization by the European Medicines Agency (EMA) in September 2020, for treatment and prevention of venous thromboembolism, pulmonary embolism, and the prevention of atherothrombotic events (3).

In August 2023, the drug as manufactured by Janssen was among the first 10 drugs announced by the Centers for Medicare & Medicaid Services (CMS) whose prices would be directly negotiated with drug companies at the end of that month (4). Negotiations were to have occurred through the end of 2024, with negotiated prices coming effective at the beginning of 2026, according to CMS at the time. The other drugs listed were Eliquis (apixaban), Jardiance (empagliflozin), Januvia (sitagliptin), Farxiga (dapagliflozin), Entresto (sacubitril/valsartan), Enbrel (etanercept), Imbruvica (ibrutinib), Stelara (ustekinumab), and Fiasp and Novolog (insulin aspart) as well as various derivatives.

A Medication Guide will be dispensed along with generic rivaroxaban, according to CDER, which will list instructions on use and safety information (1). The drug already includes a boxed warning to healthcare providers about increased risk of thrombotic events. Additionally, CDER said, epidural or spinal hematomas may occur in those patients treated with rivaroxaban who are also receiving neuraxial anesthesia or undergoing a spinal puncture. In these cases, the agency said, the hematomas could result in long-term or permanent paralysis.

References

1. CDER Division of Drug Information. FDA Approves First Generics of Xarelto (rivaroxaban). Press Release. March 10, 2025.
2. Hernandez, R. Janssen Pulls 13,500 Bottles of Xarelto, Cites Contamination. PharmTech.com, Oct. 24, 2014.
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 14–17 September 2020. Press Release. Sept. 18, 2020.
4. Playter, G. White House Sets Medicare Price Negotiation Targets. PharmTech.com, Aug. 31, 2023.