BAJAJ BROKING

Notification
No new Notification messages
🚨 Trading Holiday 🚨
The NSE and BSE will remain closed for trading and settlement on Monday, April 14, 2025, on account of Dr. B. R. Ambedkar Jayanti.
Open a Free Demat Account
Pay ZERO maintenance charges for the first year, get free stock picks daily, and more.
Trade Now, Pay Later with up to 4x
Never miss a good trading opportunity due to low funds with our MTF feature.
Track Market Movers Instantly
Stay updated with real-time data. Get insights at your fingertips.

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

Trade

1134.752.25 (4.82 %)

Updated - 15 April 2025
1138.00day high
DAY HIGH
1099.00day low
DAY LOW
1142896
VOLUME (BSE)

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

Do you have a trading account app or demat account app?

You can open an account with Bajaj Broking in minutes.

Download the Bajaj Broking app now from Play Store or App Store.

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.

For All Disclaimers Click Here: https://www.bajajbroking.in/disclaimer

Share this article: 

Read More Blogs

Our Secure Trading Platforms

Level up your stock market experience: Download the Bajaj Broking App for effortless investing and trading

Bajaj Broking App Download

9.5 lakh+ Users

icon-with-text

4+ App Rating

icon-with-text

4 Languages

icon-with-text

₹4400+ Cr MTF Book

icon-with-text