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Court of Appeals for the Federal Circuit Issues Ruling in Norwich Case that Prevents FDA Approval of Norwich’s Abbreviated New Drug Application Until 2029

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Bausch Health Companies Inc. and Salix Pharmaceuticals announced that the U.S. Court of Appeals upheld the decision preventing the approval of Norwich Pharmaceuticals' generic version of XIFAXAN until 2029. The Court also invalidated certain patents related to XIFAXAN for treating IBS-D.
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The affirmation of the U.S. Court of Appeals regarding Bausch Health's patent litigation is a significant event for the company and its stakeholders. This decision effectively extends the exclusivity period for XIFAXAN until October 2029, which is critical for maintaining the drug's market share against generic competition. From a legal standpoint, the upholding of the district court's decision indicates a strong defense of the existing patent claims that cover the drug's composition and usage.

However, it is important to note that while the exclusivity is upheld, the invalidation of certain patents related to the treatment of IBS-D by XIFAXAN could open avenues for future legal challenges. This might lead to potential litigation costs and a need for a strategic realignment of the company's intellectual property portfolio. Stakeholders can expect Bausch Health to continue investing in legal defenses to protect its market position, which could influence the company's financial planning and resource allocation.

The appellate court's decision has direct financial implications for Bausch Health. By preventing generic competition for XIFAXAN until 2029, the company secures its revenue stream from this product for several more years. This is positive news for investors as it provides a clearer revenue forecast and could potentially lead to an upward revision of the company's valuation.

On the flip side, the affirmation of patent invalidity might be a concern for investors, as it reflects vulnerability in the company's patent portfolio and could signify risks for other products. Investors should monitor Bausch Health's R&D pipeline and any strategic moves to mitigate the impact of patent cliffs on its long-term growth prospects.

The pharmaceutical market is highly sensitive to patent litigation outcomes due to the impact on competitive dynamics. Bausch Health's ability to retain exclusivity on XIFAXAN until 2029 means that the company can continue to capitalize on the established market for IBS-D treatments without the immediate pressure of price erosion from generics.

Understanding the market's response to such news is crucial. The decision may be viewed favorably by investors and could lead to an increase in stock market confidence in Bausch Health's near-term profitability. However, the market will also be aware of the invalidated patents and may expect Bausch Health to increase investment in new product development or strategic acquisitions to fill potential future revenue gaps.

LAVAL, QC / ACCESSWIRE / April 11, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. Court of Appeals for the Federal Circuit in the matter of Salix Pharmaceuticals, LTD. et al v. Norwich Pharmaceuticals, Inc., affirmed the May 17, 2023 decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals, Inc.'s motion for modification of the court's final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 550 mg before Oct. 2, 2029. The Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of XIFAXAN® for treating IBS-D. As a result of the Federal Circuit's decision, Norwich's abbreviated new drug application for XIFAXAN (rifaximin) 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029.

"We are pleased that the Federal Circuit maintained the judgment preventing the approval of Norwich's abbreviated new drug application for XIFAXAN (rifaximin) 550 mg by the U.S. Food and Drug Administration until October 2029," said Thomas J. Appio, Chief Executive Officer. "While we are disappointed that the Federal Circuit affirmed the invalidity of certain XIFAXAN IBS-D patents and disagree with this aspect of the Court's decision, we will continue to vigorously defend our intellectual property. We remain committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN, and we look forward to continuing to serve those patients."

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 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 Twitter and 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 "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company's appeal with respect to, and actions 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 amended ANDA and as to the outcome of any appeal. 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) (848) 541-3785

SOURCE: Bausch Health Companies Inc.



View the original press release on accesswire.com

FAQ

What is the latest update from Bausch Health Companies Inc. regarding XIFAXAN?

Bausch Health Companies Inc. and Salix Pharmaceuticals announced that the U.S. Court of Appeals upheld the decision preventing the approval of Norwich Pharmaceuticals' generic version of XIFAXAN until 2029.

What was the decision of the U.S. Court of Appeals regarding the patents related to XIFAXAN?

The U.S. Court of Appeals affirmed the decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of XIFAXAN for treating IBS-D.

Who is the Chief Executive Officer of Bausch Health Companies Inc.?

Thomas J. Appio is the Chief Executive Officer of Bausch Health Companies Inc.

Bausch Health Companies Inc.

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bausch health companies inc. (nyse/tsx: bhc) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. we are delivering on our commitments as we build an innovative company dedicated to advancing global health. our approximately 22,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.five pillars, or guiding principles, represent the foundation on which we are realizing our mission as an organization: people, quality health care outcomes, customer focus, innovation and efficiency. more information can be found at www.bauschhealth.com.###