Mr. Thomas J. Appio reports

BAUSCH HEALTH ANNOUNCES PATENT LAWSUIT AGAINST AMNEAL PHARMACEUTICALS

Bausch Health Companies Inc. along with its gastroenterology business, Salix Pharmaceuticals Inc., has filed a lawsuit in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals of New York LLC, Amneal EU Ltd., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals Pvt. Ltd. and Amneal Pharmaceuticals Inc. This lawsuit follows receipt of a notice of paragraph 4 certification stating that Amneal submitted an abbreviated new drug application to the U.S. Food and Drug Administration seeking approval to market a generic version of Xifaxan (rifaximin) 550-milligram tablets. Amneal asserts that certain patents listed in the FDA's orange book for Xifaxan are unenforceable, invalid and/or not infringed by Amneal's ANDA product. This action formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Amneal's ANDA.

"Bausch Health remains confident in its Xifaxan intellectual property, and we will continue to defend our Xifaxan franchise for the benefit of patients," Thomas J. Appio, chief executive officer, Bausch Health, said. "As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies."

Bausch Health has previously received paragraph 4 certifications for Xifaxan (rifaximin) 550-milligram tablets from Teva Pharmaceuticals, Sandoz Inc., Sun Pharmaceuticals and Norwich Pharmaceuticals. The company settled the matters with Teva, Sandoz and Sun in September, 2018, May, 2020, and September, 2020, respectively, while litigation with Norwich remains in progress.

About Bausch Health Companies Inc.

Bausch Health (New York Stock Exchange: BHC) (Toronto Stock Exchange: BHC) is a global diversified pharmaceutical company, enriching lives through its relentless drive to deliver better health care outcomes. It develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health through its controlling interest in Bausch + Lomb. Its ambition is to be a globally integrated health care company, trusted and valued by patients, HCPs, employees and investors.

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