Bausch Health files patent lawsuit against Amneal over generic Xifaxan
Bausch Health, along with its gastroenterology business, Salix Pharmaceuticals, has filed a lawsuit in the United States District Court for the District of New Jersey against Amneal Pharmaceuticals of New York, Amneal EU, Amneal Pharmaceuticals, Amneal Pharmaceuticals Private and Amneal Pharmaceuticals.
This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application to the Food and Drug Administration seeking approval to market a generic version of Xifaxan (rifaximin) 550 mg tablets. Amneal asserts that certain patents listed in the FDA’s Orange Book for Xifaxan are unenforceable, invalid and/or not infringed by Amneal’s ANDA product. This action formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Amneal’s ANDA.
“Bausch Health remains confident in its Xifaxan intellectual property and we will continue to defend our Xifaxan franchise for the benefit of patients,” said Thomas Appio, CEO of Bausch Health. “As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies.”
[Read more: Amneal touts 39 retail, injectable product launches in 2023]
Bausch Health has previously received Paragraph IV Certifications for Xifaxan (rifaximin) 550 mg tablets from Teva Pharmaceuticals, Sandoz, Sun Pharmaceuticals and Norwich Pharmaceuticals. The company has since settled the matters with Teva, Sandoz and Sun in September 2018, May 2020 and September 2020, respectively, while litigation with Norwich remains ongoing.
Xifaxin (rifaximin) 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.
[Read more: U.S. District Court dismisses Norwich’s lawsuit against the FDA over generic Xifaxan]