Bausch Health Announces Updates Related to Norwich XIFAXAN Matters
Bausch Health Companies (NYSE:BHC, TSX:BHC) and Salix Pharmaceuticals updated on their litigation with Norwich Pharmaceuticals. Following the US Court of Appeals' April 11, 2024 decision, both companies filed for rehearing. They expect a decision within three months. Additionally, on May 10, 2024, Norwich filed an amendment to their ANDA with the FDA, seeking approval for a generic XIFAXAN® (rifaximin) 550 mg tablets for IBS-D treatment. Bausch has 45 days to file a patent infringement lawsuit, which would delay FDA approval of Norwich's ANDA by up to 30 months or until a court decision.
- Bausch Health is actively defending its intellectual property rights for XIFAXAN®.
- The automatic FDA delay of up to 30 months if a lawsuit is filed could protect Bausch's market share.
- Anticipated decision on the rehearing within three months provides a clear timeline for investors.
- Pending litigation creates uncertainty around XIFAXAN®'s market exclusivity.
- Potential approval of a generic version by Norwich could significantly impact Bausch's revenue.
- Legal processes and potential delays could incur additional costs for Bausch Health.
Insights
The legal dispute between Bausch Health and Norwich Pharmaceuticals over XIFAXAN® is quite significant. The Court of Appeals decision and the subsequent petitions for rehearing indicate ongoing and potentially prolonged litigation. The submission of a new Paragraph IV certification by Norwich adds another layer of complexity, indicating Norwich's intent to challenge Bausch's patent protections to market a generic version of XIFAXAN®. If Bausch initiates a patent infringement lawsuit, it will delay FDA approval of Norwich's ANDA by up to 30 months, buying Bausch important time to maintain its market exclusivity.
From a legal standpoint, this news affects the company's operational stability and future earnings, as the outcome could either uphold Bausch's market position or significantly erode it if Norwich succeeds in its challenge. Investors should track these legal developments closely, as they could result in substantial changes in Bausch's financial outlook.
For investors, the ongoing litigation and potential new lawsuit are double-edged swords. On one hand, successfully delaying Norwich's ANDA could maintain Bausch's revenue streams from XIFAXAN®, a key product for the company. On the other, litigation is costly and uncertain, potentially affecting the company's financial health. Legal fees and the risk of an unfavorable ruling could introduce volatility in Bausch's stock price. The market tends to react to such legal challenges with caution, given the high stakes involved. Investors should weigh the potential short-term legal costs against the long-term benefits of extended market exclusivity for XIFAXAN®.
Additionally, the news might impact investor sentiment, leading to a possible sell-off due to increased uncertainty. It's important for investors to consider both the immediate financial impact of ongoing litigations and the strategic importance of XIFAXAN® for Bausch's overall market position.
The outcome of this legal battle will significantly impact Bausch Health's competitive position in the gastroenterology market. XIFAXAN® is a critical product for the treatment of irritable bowel syndrome with diarrhea and its patent protection is important for Bausch to fend off generic competition. The introduction of a generic version by Norwich could substantially reduce Bausch's market share and revenue from this drug.
Given the high stakes, the industry could see shifts in market dynamics based on the litigation's outcome. Patent expirations and generic competition are common challenges in the pharmaceutical industry, but this particular case highlights the aggressive tactics companies use to protect or challenge market exclusivity. Investors should understand that market dynamics in the pharma sector heavily depend on patent protections and the ability to delay generic entries.
LAVAL, QC / ACCESSWIRE / May 14, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business Salix Pharmaceuticals, today announced certain updates related to its litigation with Norwich Pharmaceuticals, Inc.
With respect to the April 11, 2024, decision of the US Court of Appeals for the Federal Circuit, both Bausch Health and Norwich have filed petitions for panel rehearing or rehearing en banc. The Company anticipates a decision on whether a rehearing will be granted within the next three months.
The Company has also received notice of a new Paragraph IV certification (the "Notice"), dated May 10, 2024, from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea in adults.
Bausch Health is reviewing the Notice and has 45 days from receipt of the Notice to commence a patent infringement lawsuit against Norwich. Bausch Health understands that such a lawsuit would automatically preclude the FDA from approving Norwich's ANDA for up to 30 months or until the issuance of a decision by the district court in this matter that is adverse to Bausch Health, whichever occurs first.
Bausch Health intends to vigorously enforce its intellectual property rights relating to XIFAXAN®.
About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company's actions and plans to vigorously defend its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or as to the outcome of any patent litigation. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Investor Contact:
Garen Sarafian
ir@bauschhealth.com
(877) 281-6642 (toll free)
Media Contact:
Kevin Wiggins
corporate.communications@bauschhealth.com
(908) 541-3785
SOURCE: Bausch Health Companies Inc.
View the original press release on accesswire.com
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