Bausch Health Takes Legal Action Against Amneal
Bausch Health, in association with Salix Pharmaceuticals, Inc., has launched a lawsuit against Amneal Pharmaceuticals and its affiliates. This move was prompted by Amneal’s submission of an abbreviated new drug application (ANDA) to the FDA for the sale of a generic version of Salix’s flagship drug Xifaxan (rifaximin) 550 mg tablets.
Stakes Around Xifaxan
Xifaxan 550 mg tablets play a vital role in managing hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea (IBS-D) in adults. Amneal has challenged the validity and enforceability of certain patents related to Xifaxan listed in the FDA’s Orange Book.
Impact on Revenue and Market Standing
The lawsuit invokes the Hatch-Waxman Act, introducing a 30-month halt on potential FDA approval for Amneal’s ANDA. Any adverse ruling would significantly affect sales as Xifaxan comprised about 80% of the Salix unit’s revenues in 2023, amounting to $2.2 billion.
Historical Legal Battles Involving Xifaxan
Bausch Health has previously faced legal challenges regarding Xifaxan. The company had a run-in with Norwich Pharmaceuticals, resulting in a final judgment in August 2022 that could delay generic competition until 2029. Appeals and counteractions continue in this ongoing legal saga.
Financial Insight and Investment Considerations
Bausch Health currently holds a Zacks Rank #3 (Hold). For investors seeking more promising options in the biotech space, stocks like ADMA Biologics, Inc. and ANI Pharmaceuticals, Inc. sport a Zacks Rank #1 (Strong Buy). Both these companies have shown significant growth potential and performance in recent times.
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Disclaimer: The views and opinions expressed are solely those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
