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.
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
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.
More from Generics
• By
Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.
• By
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
• By
Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
More from Business
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.