Aurobindo Gets USFDA Nod to Launch Generic Xarelto 2.5mg in $447M US Market
Published • 13 April 2025 at 10:24 AM
Aurobindo Pharma Gets USFDA Nod for Generic Xarelto 2.5mg
Aurobindo Pharma has received final approval from the USFDA to manufacture and market Rivaroxaban Tablets USP, 2.5mg — the generic version of Janssen’s blockbuster drug Xarelto. The Hyderabad-based pharmaceutical company plans to launch the product in Q1 of FY2025-26. The US market for this strength alone is estimated at $447 million for the 12 months ending February 2025, according to IQVIA. In addition, Aurobindo has secured tentative USFDA approvals for Rivaroxaban in 10mg, 15mg, and 20mg strengths, targeting a broader $8.5 billion US market for all doses. Rivaroxaban is an anticoagulant used to reduce stroke and embolism risks in patients with nonvalvular atrial fibrillation, and for treating or preventing deep vein thrombosis (DVT) and pulmonary embolism (PE). This milestone brings Aurobindo’s total USFDA-approved ANDAs to 540, including 521 final and 19 tentative approvals. With operations in over 150 countries, Aurobindo continues to expand its diverse portfolio across key therapeutic areas such as CNS, cardiovascular, anti-retrovirals, gastroenterology, anti-diabetics, and antibiotics.
Generic Xarelto Launch: Aurobindo's USFDA Approval
- USFDA Approval: Aurobindo Pharma received final USFDA approval to manufacture and market Rivaroxaban Tablets USP, 2.5mg — the generic version of Xarelto.
- Product Launch: The company plans to launch the product in Q1 of FY2025-26.
- Market Value: The US market for the 2.5mg strength is valued at approximately $447 million (as of February 2025, IQVIA data).
- Tentative Approvals: Aurobindo also secured tentative USFDA approvals for 10mg, 15mg, and 20mg Rivaroxaban tablets.
- Total Market Opportunity: The full US market for all Rivaroxaban strengths is estimated at $8.5 billion.
- Therapeutic Use: Rivaroxaban is an anticoagulant used to prevent stroke, DVT, and pulmonary embolism.
- ANDA Milestone: Aurobindo now has 540 ANDA approvals from the USFDA — 521 final and 19 tentative.
- Global Reach: The company operates in over 150 countries.
- Therapeutic Coverage: Aurobindo’s portfolio includes CNS, cardiovascular, anti-retrovirals, gastroenterology, anti-diabetics, and antibiotics.
- Strategic Growth: This approval strengthens Aurobindo’s presence in the high-value US generics market.
