Aurobindo Pharma receives FDA OK for generic Xarelto

Aurobindo has obtained the Food and Drug Administration’s green light for rivaroxaban tablets, 2.5 mg, which is the generic of Janssen’s Xarelto. 

Rivaroxaban tablets are used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis, pulmonary embolism, and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

Rivaroxaban tablets, 2.5 mg, have a market value of roughly  $447 million for the 12 months ending February 2025, per IQVIA. 

[Read more: Aurobindo obtains FDA OK for generic Keflet]

The FDA also has given tentative approval for rivaroxaban, in dosage strengths of 10 mg, 15 mg and 20 mg. 

The market value for all of the strengths of rivaroxaban tablets is approximately $8.5 billion for the 12 months ending February 2025, per IQVIA.

[Aurobindo Pharma inks product development deal with global pharma company]