Indian pharma major Lupin has officially introduced a generic version of Janssen’s VTE drug, rivaroxaban, in the U.S. market. This move comes after receiving the required U.S. FDA approval, enabling Lupin to compete in the anticoagulant and blood clot prevention segment.
Rivaroxaban is used to treat venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE), and to prevent recurrence of clots. The drug also helps reduce the risk of stroke in patients with non‑valvular atrial fibrillation. Lupin will produce the generic version at its manufacturing facilities in India.
This launch strengthens Lupin’s footprint in high‑growth U.S. generics and boosts access for patients needing critical anticoagulant therapy. The original brand, marketed by Janssen, was a leading name in cardiovascular medicines and had significant sales in the U.S. Lupin’s entry is expected to push down costs and improve affordability.
By offering a bioequivalent version under full regulatory compliance, Lupin aims to capture market share in the VTE drug segment. This step aligns with its broader strategy to lead in cardiovascular, specialty, and high-value generic drugs. The launch underscores Lupin’s ambition to be a major player in the global generic pharmaceutical market.
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