Bausch Health files patent lawsuit against Amneal Pharma for its liver disease drug – News Healthcare

Bausch Health Companies Inc. along with its gastroenterology business, Salix Pharmaceuticals, Inc., has filed a lawsuit in the United States District Court against Amneal Pharmaceuticals.

According to a report by Pharmabiz, this lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market a generic version of Xifaxan (rifaximin) 550 mg tablets.

The report reveals that 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,” Thomas J. Appio, CEO, Bausch Health said as quoted by Pharmabiz. “As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies.”

Bausch Health has previously received Paragraph IV Certifications for Xifaxan (rifaximin) 550 mg tablets from Teva Pharmaceuticals, Sandoz Inc., 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.

Xifaxan (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.

Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases.

Bausch Health Companies Inc. is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. The company develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through its controlling interest in Bausch + Lomb.