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Aurobindo Pharma Gets USFDA Nod for Generic Xarelto 2.5mg Tablets

Synopsis:

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.

Also read: HAL Denies Selecting PwC for R&D Benchmarking Amid Ongoing Bids

AUROBINDO PHARMA LTD

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1229.119.50 (1.61 %)

Updated - 30 April 2025
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Key Takeaways:

  • 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.

Also read: Glenmark, Sun Pharma, Zydus Recall Drugs in US over Compliance Issues

Product Approval Snapshot

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

Expanding Market Presence

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.

Also read: Dr Reddy’s Denies Workforce Reduction Claims Amid Cost-Cut Rumours

Disclaimer: Investments in the securities market are subject to market risk, read all related documents carefully before investing.

This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

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