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Aurobindo Pharma has received final approval from the USFDA to manufacture and sell Rivaroxaban Tablets USP, 2.5mg. This drug is the generic equivalent of Janssen Pharmaceuticals' blockbuster drug, Xarelto 2.5mg. The Hyderabad-based pharma major has announced plans to launch this product in the first quarter of the financial year 2025-26.
According to IQVIA data, the US market for Rivaroxaban Tablets is estimated to have sales of approximately $447 million for the twelve months ending February 2025, which is a strategic milestone for Aurobindo Pharma to strengthen its foothold in the high-value US generic market.
Potential approvals for higher potency drugs also
To further strengthen its pipeline, Aurobindo Pharma has also received potential approvals from the USFDA for 10mg, 15mg and 20mg strengths of Rivaroxaban Tablets USP. These higher potency dosage forms are part of a significant larger opportunity. According to IQVIA, the total US market sales for Rivaroxaban Tablets of all strengths for the same period is estimated at $8.5 billion. What is the problem for which the drug is used? Rivaroxaban Tablets is a widely used anticoagulant, prescribed to reduce the risk of stroke and systemic embolism in patients suffering from non-valvular atrial fibrillation. It is also recommended for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and prevention of DVT after hip or knee replacement surgery. With this, Aurobindo Pharma has now received a total of 540 Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 521 final approvals and 19 potential approvals. How is the stock performance Talking about the company's stock performance, on Friday it closed at Rs 1084 per share with a gain of 2.5%. The market capitalization of Aurobindo Pharma is around Rs 63 thousand crores. Its 52-week high is Rs 1592 and 52-week low is Rs 1010 per share. The stock has been flat in the last one month, but the stock has seen a gain of 27% in the last 6 months. This year so far, the stock has slipped by about 20%.
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