Lupin Risks First US Xarelto Generic Launch After PTAB Knocked Out Key Patent

Bayer Has Appealed PTAB’s 2023 Decision On ‘310 Patent; Other Action Stayed Pending Result

12 Mar 2025

Lupin has moved quickly to begin rolling out the first generic version of the blockbuster blood thinner Xarelto in the US, despite continued legal action over a patent expiring in 2039.

Businessman showing risk level indicator rating since low to high for risk management and assessment review concept — • Source: Shutterstock

Lupin has pressed on ‘at-risk’ with the launch of the first generic version of Johnson & Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets, with litigation ongoing over a key patent expiring in 2039.

The Indian firm, citing IQVIA data, put annual US sales of Xarelto 2.5mg at around $446m, having launched its rivaroxaban...