Bausch Health and its gastroenterology business, Salix Pharmaceuticals, today announced that it has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Norwich Pharmaceuticals, Inc.
This lawsuit was filed in connection with the Notice of Paragraph IV Certification, dated May 10, 2024, received from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN (rifaximin) 550 mg tablets for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
Bausch Health continues to defend challenges to its XIFAXAN intellectual property. In the first Norwich lawsuit, the U.S. District Court for the District of Delaware issued a ruling in August 2022 that barred Norwich's first ANDA for XIFAXAN 550 mg from approval by the U.S. Food and Drug Administration until October 2029. On appeal, the ruling was confirmed.
Since the District Court's ruling, Bausch Health received additional patents related to XIFAXAN 550 mg that protect the innovative treatment of IBS-D. As part of the applications to the U.S. Patent and Trademark Office the Company provided information related to the ongoing dispute between the Company and Norwich, including the District Court's August 2022 decision.
As a leader in gastrointestinal health, Bausch Health will continue to vigorously defend our intellectual property and is committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN. We look forward to continuing to serve our patients, as every patient deserves better health outcomes and the chance to make the most of life.
