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Bausch Health Files Lawsuit Against Sandoz For Infringement Of Patents Protecting XIFAXAN® 550 mg Tablets
BRIDGEWATER, N.J., Oct. 1, 2019 /CNW/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") along with its wholly owned subsidiary, Salix Pharmaceuticals ("Salix"), which is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, together with Salix's licensor Alfasigma SpA (collectively the "Salix Parties"), today announced that the Company has filed a lawsuit against Sandoz Inc., a Novartis division, alleging patent infringement of 14 patents by Sandoz's filing of its Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg tablets.
Bausch Health remains confident in the strength of the XIFAXAN patents and will continue to vigorously defend its intellectual property. XIFAXAN is protected by 22 patents covering the composition of matter and the use of XIFAXAN listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.
In September 2018, Bausch Health agreed to resolve the outstanding intellectual property litigation with Actavis Laboratories FL, Inc. ("Actavis"), regarding XIFAXAN 550 mg tablets. Under the terms of the agreement, the Salix Parties will grant Actavis a non-exclusive license effective Jan. 1, 20281 to the Salix Parties' intellectual property relating to XIFAXAN 550 mg tablets in the United States.
Alfasigma is a privately-owned, Italy-based integrated multinational pharmaceutical company with 2018 revenues in excess of €1 billion, 5 manufacturing plants, R&D facilities, and 3,000 employees globally. Outside of its core Italian market, Alfasigma has 16 subsidiaries in Europe, Asia, North and Central America and Africa, and is present in more than 90 countries. More than 44% of Alfasigma turnover comes from internally developed proprietary products. More information is available at the Alfasigma website at: http://www.alfasigma.com/en.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market 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. More information can be found at www.bauschhealth.com.
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. 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. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in the Company's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including that the risks and uncertainties outlined above will not cause actual results or events to differ materially from those described in these forward-looking statements. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable, but 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. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
- Actavis will be able to begin marketing the medicine earlier if another generic rifaximin product is granted approval and starts selling or distributing such generic rifaximin product before Jan. 1, 2028.
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