Chugai Pharmaceutical (TYO: 4529) says that, along with majority-owner Roche (ROG: SIX) and Genentech, has filed a patent infringement lawsuit in the US District Court for the District of Delaware as follows.
The Japanese drugmaker explains the Fresenius Kabi USA, and affiliates have filed an Abbreviated New Drug Application (ANDA) for approval of a generic version of Alecensa (alectinib), an ALK inhibitor, anti-cancer agent to the US Food and Drug Administration.
Under the framework of the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman Act), Chugai, Roche and Genentech filed a patent infringement lawsuit against Fresenius alleging submission of ANDA infringed Chugai’s US Patents (Nos 9,126,931; 9,440,922; 9,365,514 and 10,350,214).
No changes are expected to be made to Chugai’s financial prospects at this point.
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