Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation

Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation

— Organization to Attraction Anticipated Court docket Choice on Particular XIFAXAN® Patents –

LAVAL, Quebec, July 28, 2022 /PRNewswire/ — Bausch Health Providers Inc. (NYSE/TSX: BHC), and its gastroenterology company Salix Pharmaceuticals, these days announced the U.S. District Court docket of Delaware issued an Oral Order in the matter of Salix Prescription drugs, Ltd. et al v. Norwich Prescribed drugs, Inc. with regards to the infringement and validity of selected U.S. Patents defending the composition and use of XIFAXAN® (rifaximin) 550 mg tablets for the remedy of irritable bowel syndrome with diarrhea (IBS-D) and reduction in chance of overt hepatic encephalopathy (HE) recurrence.

The Oral Buy suggests that the Courtroom will uncover specified U.S. Patents preserving the use of XIFAXAN® (rifaximin) 550 mg tablets for the reduction in hazard of HE recurrence legitimate and infringed and U.S. Patents safeguarding the composition, and use of XIFAXAN® for dealing with IBS-D invalid. Even though the Courtroom has not nonetheless entered any closing judgement, absent Norwich’s elimination of the HE indication and data from their Abbreviated New Drug Application (ANDA), it is anticipated that the Court docket will enjoin Norwich’s pending ANDA right up until expiration of the XIFAXAN® HE Patents in 2029. The Enterprise intends to vigorously oppose any attempt by Norwich to take out the HE basic safety information from its ANDA in an exertion to stay away from the XIFAXAN® HE Patents.

The Food and drug administration has stated that they approach to make a main revision to the rifaximin product or service particular direction to include an in vivo bioequivalency research. Until eventually an acceptance of a revised ANDA is granted by the Food and drug administration and the anticipated injunction modified by the Court, Norwich is not permitted to launch a generic equal of XIFAXAN®.

When the Court enters a remaining order, Bausch Health and fitness will think about all accessible possibilities to vigorously defend the mental home protecting XIFAXAN® and will appeal the Court’s choice to the U.S. Court docket of Appeals for the Federal Circuit.

“We are dissatisfied with today’s growth. We strongly disagree with any summary that our patents are not legitimate and intend to file an enchantment to any these order,” Thomas J. Appio, CEO, Bausch Well being, reported. “As a chief in gastrointestinal wellness, shielding our intellectual residence is necessary to our ability to keep on to establish modern therapies. We intend to vigorously go after all obtainable choices to challenge any remaining ruling, when also continuing to push development and innovation for our XIFAXAN® franchise.”

Bausch Health and fitness has earlier entered into settlement agreements with Teva, Solar Prescribed drugs, and Sandoz to allow a generic rifaximin item entry in 2028 or on an previously acceptance and launch of a generic rifaximin solution. Till, and if, Norwich secures Food and drug administration approval for its generic rifaximin product or service and subsequently launches a generic rifaximin item, Teva, Sunlight Pharmaceuticals, and Sandoz will not be permitted to start a generic edition of XIFAXAN® tablets just before 2028.

The Corporation intends to file an enchantment instantly right after any ultimate get is issued, assuming it is dependable with the Oral Get.


XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in chance of overt hepatic encephalopathy (HE) recurrence in adults and for the cure of irritable bowel syndrome with diarrhea (IBS-D) in grown ups.

About Salix

Salix Prescription drugs is a person of the most significant specialty pharmaceutical firms in the planet dedicated to the avoidance and treatment method of gastrointestinal conditions. For additional than 30 a long time, Salix has accredited, formulated and marketed progressive merchandise to increase patients’ life and arm wellbeing treatment vendors with lifetime-altering answers for lots of chronic and debilitating problems. Salix at this time markets its merchandise line to U.S. health and fitness care suppliers through an expanded revenue pressure that focuses on gastroenterology, hepatology, discomfort experts and major care. Salix is headquartered in Bridgewater, New Jersey. For more information and facts about Salix, stop by and join with us on Twitter and LinkedIn.

About Bausch Health

Bausch Well being Companies Inc. (NYSE/TSX: BHC) is a worldwide diversified pharmaceutical enterprise whose mission is to strengthen people’s lives with our health care merchandise. We acquire, manufacture and current market a assortment of goods generally in gastroenterology, hepatology, neurology, dermatology, international prescription drugs and eye wellness, by way of our somewhere around 90{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} possession of Bausch + Lomb Corporation. With our top long lasting manufacturers, we are offering on our commitments as we establish an progressive corporation committed to advancing world wide well being. For far more information, take a look at and link with us on Twitter and LinkedIn.

Forward-seeking Statements

This news launch could consist of ahead-on the lookout statements about the long run overall performance of Bausch Wellness, which may well frequently be recognized by the use of the words and phrases “anticipates,” “hopes,” “expects,” “intends,” “designs,” “should,” “could,” “would,” “may possibly,” “believes,” “topic to” and versions or similar expressions, such as statements about the timing and information of the long term designs for Solta and its foreseeable future efficiency. These statements are based mostly on the current anticipations and beliefs of administration and are subject to selected pitfalls and uncertainties that could cause true results to vary materially from those explained in the forward-seeking statements. In particular, Bausch Well being can give no assurance that the Court docket will challenge a remaining judgment reliable with the Oral Order, as to the timing of any approval by the Fda of any ANDA or amended ANDA and as to the end result of any appeal. Precise benefits are subject matter to other pitfalls and uncertainties that relate far more broadly to Bausch Health’s all round business enterprise, together with people a lot more fully described in Bausch Health’s most new annual report on Sort 10-K and in-depth from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Fee and the Canadian securities administrators, which elements are included herein by reference.


Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation

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