Bausch Health Brings Patent Infringement Lawsuit Against Norwich Pharmaceuticals
Bausch Health announced that it has filed a patent infringement lawsuit against Norwich Pharmaceuticals in the U.S. District Court for the District of New Jersey. This action follows a Notice of Paragraph IV Certification received on May 10, 2024, from Norwich, indicating their submission of an amendment to an Abbreviated New Drug Application (ANDA) to the FDA. This amendment seeks approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets, used for treating diarrhea-predominant irritable bowel syndrome (IBS-D). Bausch Health has a history of defending its XIFAXAN® intellectual property, evidenced by a 2022 U.S. District Court ruling that blocked Norwich's first ANDA until October 2029. The company has since obtained additional patents related to XIFAXAN® 550 mg. Bausch Health is determined to protect its intellectual property and ensure patient safety and access to XIFAXAN®.
- Bausch Health has a strong track record of defending its XIFAXAN® intellectual property, with a prior court ruling preventing generic competition until 2029.
- The company has secured additional patents for XIFAXAN® 550 mg, strengthening its patent portfolio.
- The ongoing patent litigation could result in costly legal expenses.
- Potential market entry of generic alternatives could impact future revenues from XIFAXAN® 550 mg.
Insights
The patent infringement lawsuit filed by Bausch Health against Norwich Pharmaceuticals is an important event for investors. Such legal actions can have significant implications for both companies involved. Patent litigation in the pharmaceutical sector often revolves around protecting intellectual property rights for profitable drugs. In this case, XIFAXAN® is a key product for Bausch Health, used for treating irritable bowel syndrome with diarrhea (IBS-D).
Bausch Health's strategy of defending its patents ensures that it maintains market exclusivity for XIFAXAN® until 2029. This is important because generic competition can drastically reduce the revenue generated by branded drugs. By filing this lawsuit, Bausch Health is trying to extend its monopoly, which would protect its revenue streams for the coming years. Investors should be aware that patent litigation is both costly and time-consuming, but the potential rewards of maintaining exclusivity are substantial.
However, it's essential to note that the outcome of legal battles is uncertain. While Bausch Health has been successful in previous litigation against Norwich, which resulted in a ruling barring Norwich’s ANDA until 2029, ongoing disputes may yield different results. Legal costs and potential settlements might also impact the financials in the short term.
Considering these factors, investors should closely monitor the progress of this lawsuit, as it could significantly affect Bausch Health's market position and financial health.
The patent infringement lawsuit highlights the competitive landscape in the pharmaceutical industry, especially within the gastrointestinal health sector. For Bausch Health, XIFAXAN® is not just a product but a major revenue driver. The fight to keep generics off the market underscores how valuable this drug is to the company’s portfolio. Historically, once a blockbuster drug like XIFAXAN® faces generic competition, the branded version’s sales can decline by over
From a market perspective, delaying generic entry allows Bausch Health to continue benefiting from premium pricing. This means sustained high margins and revenue streams, which is favorable for investors focused on profitability. Furthermore, any delay in the introduction of a generic version by Norwich means sustained market share for Bausch and an indirect barrier for other potential generic competitors.
For retail investors, understanding the dynamics of patent protection and its financial implications is crucial. The legal environment and market exclusivities heavily influence the profitability and valuation of pharmaceutical companies. Thus, this lawsuit serves as a reminder of the significant role played by intellectual property in sustaining competitive advantage in the pharma industry.
LAVAL, QC / ACCESSWIRE / June 20, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company") and its gastroenterology business, Salix Pharmaceuticals, today announced that it has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Norwich Pharmaceuticals, Inc.
This lawsuit was filed in connection with the Notice of Paragraph IV Certification, dated May 10, 2024, received 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 diarrhea-predominant irritable bowel syndrome (IBS-D).
Bausch Health continues to defend challenges to its XIFAXAN® intellectual property. In the first Norwich lawsuit, the U.S. District Court for the District of Delaware issued a ruling in August 2022 that barred Norwich's first ANDA for XIFAXAN® 550 mg from approval by the U.S. Food and Drug Administration until October 2029. On appeal, the ruling was confirmed.
Since the District Court's ruling, Bausch Health received additional patents related to XIFAXAN® 550 mg that protect the innovative treatment of IBS-D. As part of the applications to the U.S. Patent and Trademark Office the Company provided information related to the ongoing dispute between the Company and Norwich, including the District Court's August 2022 decision.
As a leader in gastrointestinal health, Bausch Health will continue to vigorously defend our intellectual property and is committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN®. We look forward to continuing to serve our patients, as every patient deserves better health outcomes and the chance to make the most of life.
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/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: | Media Contact: |
| Garen Sarafian | Kevin Wiggins |
| ir@bauschhealth.com | corporate.communications@bauschhealth.com |
| (877) 281-6642 (toll-free) | (908) 541-3785 |
SOURCE: Bausch Health Companies Inc.
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FAQ
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