Bausch Health brings patent infringement lawsuit against Norwich Pharmaceuticals over generic Xifaxan
Bausch Health and its gastroenterology business, Salix Pharmaceuticals, announced that it has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Norwich Pharmaceuticals.
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 Food and Drug Administration an amendment to an Abbreviated New Drug Application requesting approval to market a generic version of Xifaxan (rifaximin) 550 mg tablets for the treatment of diarrhea-predominant irritable bowel syndrome.
[Read more: U.S. District Court dismisses Norwich’s lawsuit against the FDA over generic Xifaxan]
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 FDA until October 2029. On appeal, the ruling was confirmed.
[Read more: Bausch wins U.S. appeal to block Norwich’s generic Xifaxan]
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,” Bausch said.
[Read more: Bausch Health files patent lawsuit against Amneal over generic Xifaxan]
Xifaxan 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea in adults.