Bausch Health filed a patent lawsuit against Amneal Pharmaceuticals over Xifaxan.
The lawsuit alleges Amneal submitted an Abbreviated New Drug Application to the FDA for approval to market a generic version of the drug, which is intended to treat irritable bowel syndrome with diarrhea, Bausch said in an April 5 news release. But Amneal asserts that patents in the FDA's Orange Book for Xifaxan are unenforceable, invalid, and/or not infringed by Amneal's ANDA product.
Bausch Health has Paragraph IV Certifications for the drug. Bausch Health's lawsuit has now triggered a 30-month stay of any potential FDA approval for Amneal's product, and litigation under the Hatch-Waxman Act is underway.
"Bausch Health remains confident in its Xifaxan intellectual property and we will continue to defend our Xifaxan Franchise for the benefit of patients," Thomas Appio, CEO of the company, said in the release. "As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies."
Amneal Pharmaceuticals didn't immediately respond to a request for comment from Becker's.