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Aurobindo Pharma has secured final USFDA approval for Rivaroxaban 2.5mg tablets, eyeing a $447 million market in the US. It also received tentative nods for 10mg, 15mg, and 20mg variants.
Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and sell Rivaroxaban 2.5mg tablets in the United States, the generic equivalent of the anticoagulant drug Xarelto. The company plans to launch the product in Q1 of FY2025-26, tapping into an estimated $447 million market opportunity in the US.
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Final USFDA Approval: For Rivaroxaban 2.5mg tablets, equivalent to Janssen’s Xarelto.
Market Size: Estimated at $447 million in the US for the 2.5mg strength as of February 2025.
Launch Timeline: Expected in Q1 of FY2025-26.
Tentative Approvals: Also received for 10mg, 15mg, and 20mg dosages.
Total US Market for Rivaroxaban (all strengths): Valued at $8.5 billion.
ANDA Approvals: Now stands at 540 in total, with 521 final and 19 tentative approvals.
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Dosage Strength | Approval Status | Market Size (US) |
Rivaroxaban 2.5mg | Final Approval | $447 million |
Rivaroxaban 10mg | Tentative Approval | Part of $8.5 billion |
Rivaroxaban 15mg | Tentative Approval | Part of $8.5 billion |
Rivaroxaban 20mg | Tentative Approval | Part of $8.5 billion |
The approval reinforces Aurobindo Pharma’s growing presence in the high-value US generics market. Rivaroxaban is a critical medication used to reduce the risk of stroke and treat conditions like deep vein thrombosis and pulmonary embolism. The tentative approvals for higher dosages further position the company to tap into the broader $8.5 billion US market for all Rivaroxaban strengths.
With operations in over 150 countries, Aurobindo Pharma continues to build a robust pipeline across therapeutic areas including CNS, cardiovascular, anti-retrovirals, and antibiotics. Its 30 manufacturing and packaging facilities have global regulatory endorsements.
The development may influence Aurobindo Pharma share price, especially as the company expands its foothold in the competitive US pharma space. With further product launches and approvals in sight, market participants will closely monitor Aurobindo Pharma share price movements in the coming quarters. Any substantial scale-up in generics could provide a positive boost to Aurobindo Pharma share price.
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