Bausch Health Companies Inc (BHC)

Bausch Health (BHC) stock declined by 6.92% following the being involved in multiple litigations related to its drug Xifaxan (rifaximin). In addition to the lawsuit against Amneal Pharmaceuticals, there is an ongoing litigation with Norwich Pharmaceuticals regarding the same drug.

• litigation with Amneal: The lawsuit was filed by Bausch Health (BHC), along with its gastroenterology business, Salix Pharmaceuticals, Inc, in response to Amneal's attempt to market a generic version of Salix's lead drug, Xifaxan (rifaximin) 550 mg tablets, which is used for the reduction in risk of hepatic encephalopathy recurrence and the treatment of irritable bowel syndrome with diarrhea in adults.The lawsuit triggers a 30-month stay of any potential FDA approval for Amneal's generic drug. This means that during the litigation process, Amneal's generic version of Xifaxan cannot receive FDA approval, allowing Salix Pharmaceuticals to maintain its exclusivity in the market for a longer period.
• Impact on Revenue: Xifaxan accounted for approximately 80% of Salix's revenues in 2023, amounting to $2.2 billion. If Amneal were to successfully launch a generic version of Xifaxan, it could potentially erode Salix's market share and significantly impact its revenue. Investors may be concerned about the potential loss of such a significant revenue stream.
• Litigation with Norwich: The litigation with Norwich Pharmaceuticals began in 2020 when Norwich filed an ANDA challenging the patents listed for Xifaxan. Bausch Health filed a lawsuit alleging patent infringement, leading to a 30-month stay on Norwich's ANDA approval. In August 2022, the court found the patents protecting Xifaxan for hepatic encephalopathy valid and infringed but deemed the patents for treating irritable bowel syndrome invalid. Both parties appealed the decision. Norwich removed the indication from its ANDA and filed a motion to modify the FDA's decision. Bausch Health opposed the motion, and the District Court denied Norwich's request, preventing FDA approval until October 2029. Norwich appealed to the U.S. Court of Appeals, and Bausch Health awaits a decision
• Future outlook: The complex and ongoing litigations surrounding Xifaxan, involving multiple companies and patent disputes, can contribute to market uncertainty and potentially impact Bausch Health's stock price. Investors concerned about the outcome of these lawsuits and their potential impact on the exclusivity and profitability of Xifaxan.

Shares of Bausch Health Companies (BHC) were down 7.77% on Tuesday after the company announced that Chief Financial Officer Tom Vadaketh was departing and the company had a CFO transition plan.

https://www.fool.com/investing/2023/09/19/why-shares-of-bausch-health-companies-fell-tuesday/

BHC's stock fell 8.69% following the Food and Drug Administration (FDA)'s tentative approval of an abbreviated new drug application (ANDA) from Norwich Pharmaceuticals for Xifaxan, one of the company's leading therapies. This news worried investors as it posed a threat of generic competition for Bausch.

https://www.fool.com/investing/2023/06/06/why-bausch-health-companies-stock-is-tanking-today/

BHC fell 20.4% on revenue and earnings misses. The company reported revenue of $1.94 billion in Q1 2023, against $1.92 billion in Q1 2022.

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