US Court Shoots Down Norwich In ‘Unprecedented’ Xifaxan ‘Skinny Label’ Claim
Delaware Court ‘Hesitant To Be The First’ To Allow Relief Claim To Proceed
Coming down heavily on Norwich Pharmaceuticals, a US district court has denied the US-based generics firm’s bid for relief post-judgment in a case involving the “hotly disputed” issue of skinny label ANDA products.
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The companies got US FDA approval for the drug, which they said is the only approved medicine that targets tear evaporation rather than tear production, though its mechanism is not fully understood.
Sandoz has joined a fellow major generics player, Teva’s Actavis, in settling itself out of litigation with Bausch Health over Xifaxan 550mg tablets in the US. The two settlement agreements contain key similarities and differences.
Teva’s Actavis will be able to offer a generic alternative to Bausch Health’s Xifaxan (rifaximin) 550mg tablets in the US around two years before the longest-lasting US patent protecting the gastrointestinal drug expires. Under the terms of a patent-litigation settlement that ends proceedings in a Delaware district court, Actavis can market, without royalties, its own approved generic of Xifaxan 550mg from 1 January 2028. Alternatively, from the same date, the generics firm can license restricted supplies of an authorised generic.