First Xarelto Generics Waved Through In The US: When Will They Launch?

Lupin And Sun Pharma’s Taro Win Approvals For Rivaroxaban 2.5mg Tablets

10 Mar 2025

Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.

first to hit the line — • Source: Shutterstock

Lupin and Sun Pharma’s Taro have received the first US Food and Drug Administration approvals for a generic version of Johnson & Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) – although only in the reference brand’s lowest dosage form, and with launch details thin on the ground.

The generics firms’ rivaroxaban 2.5mg tablets are indicated to reduce the risk of major cardiovascular events in adult patients with...