Bayer and Janssen Pharmaceuticals have sued Breckenridge Pharmaceutical for allegedly infringing two patents related to the deep vein thrombosis treatment drug Xeralto (rivaroxaban).
The patents, US numb ers 7,157,456 and 7,592,339, belong to Bayer and are sublicensed to Janssen.
The case was filed in the US District Court for the District of Delaware on Monday, July 25.
Bayer and Janssen targeted Breckenridge after it filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration seeking approval to produce a generic version of Xeralto in the US.
According to the complaint, Breckenridge intends to release the generic as soon as it receives approval of the ANDA and before the expiration of the patents.
In the complaint, Bayer said: “Unless Breckenridge is enjoined from infringing … actively inducing infringement and contributing to the infringement by others … plaintiffs will suffer irreparable injury.”