Warchi
Bausch Health (NYSE:BHC) has filed a patent lawsuit challenging a generic version of the Canadian pharma giant’s bowel disease drug Xifaxan that Amneal Pharmaceuticals (NASDAQ:AMRX) seeks to market in the U.S.
In filing a lawsuit in a New Jersey District Court after Amneal (AMRX) sought U.S. approval for its product, Bausch Health (BHC) alleged that the company has infringed on certain Xifaxan patents listed in the FDA’s Orange Book.
“Bausch Health remains confident in its XIFAXAN intellectual property, and we will continue to defend our XIFAXAN franchise for the benefit of patients,” CEO Thomas Appio noted in a statement late Friday. The lawsuit prevents a potential FDA approval of the product for 30 days.
In 2020, Bausch Health (BHC) reached agreements with generic drugmakers, including Teva Pharmaceuticals (TEVA) and Novartis’ (NVS) (OTCPK:NVSEF) spinoff Sandoz (OTCQX:SDZNY) (OTCQX:SDZXF) to settle patent disputes related to Xifaxan.
Another legal dispute with privately held generic drugmaker Norwich Pharmaceuticals is ongoing.