U.S. District Court Grants Summary Judgment in Favor of FDA, Salix, and Teva, and Against Norwich
Bausch Health (NYSE/TSX: BHC) and its subsidiary Salix Pharmaceuticals announced a significant legal victory as the U.S. District Court for the District of Columbia ruled in favor of FDA, Salix, and Teva in a lawsuit filed by Norwich Pharmaceuticals.
The court denied Norwich's motion for preliminary injunction regarding its ANDA for XIFAXAN® (rifaximin) 550 mg. Norwich had challenged FDA's decision to issue tentative approval for their application and the agency's handling of Teva's 180-day exclusivity period. Norwich argued that the FDA's determination would prevent them from marketing their products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028.
The District Court granted summary judgment supporting FDA, Salix, and Teva's position, effectively closing the case.
Bausch Health (NYSE/TSX: BHC) e la sua controllata Salix Pharmaceuticals hanno ottenuto una importante vittoria legale, poiché il Tribunale Distrettuale degli Stati Uniti per il Distretto di Columbia ha deciso a favore della FDA, di Salix e di Teva in una causa intentata da Norwich Pharmaceuticals.
Il tribunale ha respinto la richiesta di ingiunzione preliminare presentata da Norwich riguardo al suo ANDA per XIFAXAN® (rifaximina) 550 mg. Norwich aveva contestato la decisione della FDA di concedere un'approvazione provvisoria per la loro domanda e la gestione da parte dell'agenzia del periodo di esclusività di 180 giorni di Teva. Norwich sosteneva che la determinazione della FDA avrebbe impedito loro di commercializzare i prodotti almeno fino al 29 giugno 2028, assumendo che Teva lanciasse il suo prodotto a base di rifaximina nel gennaio 2028.
Il Tribunale Distrettuale ha emesso un giudizio sommario a favore della FDA, di Salix e di Teva, chiudendo di fatto il caso.
Bausch Health (NYSE/TSX: BHC) y su subsidiaria Salix Pharmaceuticals anunciaron una importante victoria legal, ya que el Tribunal de Distrito de los Estados Unidos para el Distrito de Columbia falló a favor de la FDA, Salix y Teva en una demanda presentada por Norwich Pharmaceuticals.
El tribunal negó la moción de Norwich para una orden de restricción preliminar respecto a su ANDA para XIFAXAN® (rifaximina) 550 mg. Norwich había impugnado la decisión de la FDA de emitir una aprobación tentativa para su solicitud y el manejo del período de exclusividad de 180 días de Teva por parte de la agencia. Norwich argumentó que la determinación de la FDA les impediría comercializar sus productos al menos hasta el 29 de junio de 2028, suponiendo que Teva lance su producto de rifaximina en enero de 2028.
El Tribunal de Distrito concedió un fallo sumario apoyando la posición de la FDA, Salix y Teva, cerrando efectivamente el caso.
Bausch Health(NYSE/TSX: BHC)와 자회사 Salix Pharmaceuticals는 Norwich Pharmaceuticals가 제기한 소송에서 FDA, Salix, Teva의 손을 들어준 워싱턴 D.C. 연방지방법원의 중요한 법적 승리를 발표했습니다.
법원은 XIFAXAN® (리팍시민) 550mg에 대한 Norwich의 ANDA 예비금지명령 신청을 기각했습니다. Norwich는 FDA가 자사 신청서에 대해 잠정 승인을 내린 결정과 Teva의 180일 독점권 기간 처리에 이의를 제기했습니다. Norwich는 FDA의 결정이 Teva가 2028년 1월에 리팍시민 제품을 출시할 경우 최소 2028년 6월 29일까지 자사 제품을 판매하지 못하게 할 것이라고 주장했습니다.
연방지방법원은 FDA, Salix, Teva의 입장을 지지하는 요약판결을 내리며 사건을 사실상 종결했습니다.
Bausch Health (NYSE/TSX : BHC) et sa filiale Salix Pharmaceuticals ont annoncé une victoire juridique importante, le tribunal de district des États-Unis pour le district de Columbia ayant statué en faveur de la FDA, de Salix et de Teva dans un procès intenté par Norwich Pharmaceuticals.
Le tribunal a rejeté la demande d'injonction préliminaire de Norwich concernant son ANDA pour XIFAXAN® (rifaximine) 550 mg. Norwich contestait la décision de la FDA d'accorder une approbation provisoire pour leur demande ainsi que la gestion par l'agence de la période d'exclusivité de 180 jours de Teva. Norwich soutenait que la décision de la FDA les empêcherait de commercialiser leurs produits au moins jusqu'au 29 juin 2028, en supposant que Teva lance son produit à base de rifaximine en janvier 2028.
Le tribunal de district a rendu un jugement sommaire en faveur de la FDA, de Salix et de Teva, mettant ainsi fin à l'affaire.
Bausch Health (NYSE/TSX: BHC) und seine Tochtergesellschaft Salix Pharmaceuticals haben einen bedeutenden rechtlichen Erfolg erzielt, nachdem das US-Bezirksgericht für den Bezirk Columbia zugunsten der FDA, Salix und Teva in einer von Norwich Pharmaceuticals eingereichten Klage entschieden hat.
Das Gericht wies den Antrag von Norwich auf eine einstweilige Verfügung bezüglich ihres ANDA für XIFAXAN® (Rifaximin) 550 mg zurück. Norwich hatte die Entscheidung der FDA angefochten, eine vorläufige Zulassung für ihren Antrag zu erteilen, sowie den Umgang der Behörde mit der 180-tägigen Exklusivitätsfrist von Teva. Norwich argumentierte, dass die Entscheidung der FDA sie daran hindern würde, ihre Produkte mindestens bis zum 29. Juni 2028 zu vermarkten, vorausgesetzt Teva bringt sein Rifaximin-Produkt im Januar 2028 auf den Markt.
Das Bezirksgericht erließ ein summarisches Urteil zugunsten der FDA, Salix und Teva und beendete damit den Fall effektiv.
- Legal victory protects XIFAXAN market exclusivity until 2028
- Court decision maintains Bausch Health's patent protection strategy
- Prevents immediate generic competition from Norwich
- Generic competition from Teva expected to begin in January 2028
Insights
Court ruling blocks Norwich's generic XIFAXAN® until 2028, protecting Bausch Health's market position and revenue stream for this key product.
The U.S. District Court's summary judgment in favor of Bausch Health, Salix, FDA, and Teva represents a significant legal victory that preserves Bausch Health's market position for XIFAXAN® (rifaximin). By denying Norwich's motion, the court has effectively extended Bausch's market protection against this particular generic competitor until at least June 29, 2028.
This ruling maintains the regulatory status quo where Teva holds 180-day exclusivity for its generic version (expected launch January 2028), while Norwich remains to tentative approval. The court's decision to completely close the case, rather than leave it open for further proceedings, suggests a decisive resolution at the district court level, though Norwich could potentially appeal.
For Bausch Health investors, this represents tangible protection for what appears to be an important revenue stream. While the article doesn't quantify XIFAXAN®'s contribution to Bausch's bottom line, the CEO's statement emphasizing their commitment to patients' "sustained access" to the drug signals its strategic importance to the company's portfolio.
This decision doesn't eliminate all competitive threats—Teva's generic entry remains on the horizon—but it does prevent the more damaging scenario of multiple generic competitors simultaneously entering the market. The extended exclusivity period provides Bausch with additional years of premium pricing potential before facing increased generic competition.
Court ruling extends XIFAXAN® revenue protection through 2028, strengthening BHC's near-term financial outlook despite looming Teva generic entry.
This legal victory has meaningful financial implications for Bausch Health (NYSE:BHC), a company with a relatively modest
The ruling preserves what appears to be an important revenue stream for Bausch until at least 2028, though Teva's planned generic entry in January 2028 will eventually impact pricing and market share. For a company of Bausch's size, maintaining exclusivity for even a single significant product can materially affect overall financial performance and cash flow generation.
The competitive dynamics here are particularly notable—while Norwich argued that FDA's determination would block their market entry until June 2028, the continued protection from this additional competitor gives Bausch a more controlled competitive environment even after Teva's anticipated entry. This creates a stepped transition to generic competition rather than an immediate multi-player generic market.
Without specific revenue figures for XIFAXAN®, it's difficult to precisely quantify this benefit, but pharmaceutical products with extended patent protection typically command premium pricing that can translate to higher profit margins. For investors, this ruling reduces near-term revenue risk and provides more certainty regarding Bausch's financial trajectory through early 2028, which is particularly valuable for financial planning and debt management purposes.
LAVAL, QC / ACCESS Newswire / April 17, 2025 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Kennedy, et al. (Case No. 25-cv- 00091), denied Norwich's motion for a preliminary injunction treated as a motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration (FDA).
Norwich had asked the District Court for a judgment declaring the FDA's decision to issue tentative approval for Norwich's Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg and failure to determine Teva Pharmaceuticals USA, Inc. (Teva) had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich's ANDA for XIFAXAN® (rifaximin) 550 mg. Norwich argued that if upheld, FDA's determination will prohibit Norwich from marketing those products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028.
Today, the District Court denied Norwich's motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case.
"We are pleased with the ruling issued today by the U.S. District Court. We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to XIFAXAN," said Thomas J. Appio, CEO of Bausch Health.
Management will release first quarter financial results after market close on Wednesday, April 30, 2025, followed by a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss results and provide a business update.
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, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements 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. These statements are neither historical facts nor assurances of future performance, 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. 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 and quarterly reports 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. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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SOURCE: Bausch Health Companies Inc.
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FAQ
What is the significance of the U.S. District Court ruling for Bausch Health's XIFAXAN patent?
When will generic XIFAXAN be available according to the BHC court decision?
What was Norwich Pharmaceuticals seeking in their lawsuit against FDA regarding BHC's XIFAXAN?
How does the court ruling affect Teva's exclusivity period for generic XIFAXAN?
