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.

Bausch Health就西法山对Amneal Pharmaceuticals提起专利诉讼。Bausch在4月5日的新闻稿中表示，这起诉讼指控Amneal向FDA提交了一份简化的新药申请，以批准该药的仿制药上市，该药旨在治疗腹泻型肠易激综合征。

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.

但Amneal声称，美国食品和药物管理局（FDA）关于西法珊的橘皮书中的专利不可执行、无效和/或不受Amneal的ANDA产品的侵犯。Bausch Health拥有该药物的第四段认证。Bausch Health的诉讼现已导致美国食品和药物管理局（FDA）对Amneal产品的任何潜在批准延期30个月，并且根据《哈奇-瓦克斯曼法案》（Hatch-Waxman Act）提起的诉讼正在进行中。该公司首席执行官托马斯·阿皮奥（ThomasAppio）在新闻稿中表示，“鲍什健康（Bausch Health）仍对其西法山知识产权充满信心，我们将继续捍卫西法山特许经营权，以造福患者。”。

'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..

“作为胃肠道健康领域的领导者，保护我们的知识产权对于我们继续开发创新疗法的能力至关重要。”Amneal Pharmaceuticals没有立即回应贝克尔的置评请求。。