Bausch Health Announces Resolution Of BRYHALI® (Halobetasol

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|Dec 21|magazine16 min read

Ortho Dermatologics Will Maintain Market Exclusivity for BRYHALI Lotion Until 2026¹

LAVAL, Quebec, Dec. 20, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, have agreed to resolve the outstanding intellectual property litigation with Glenmark Pharmaceuticals, Ltd. (Glenmark), regarding BRYHALI® (halobetasol propionate) Lotion, 0.01%. The Company will grant Glenmark a non-exclusive license effective 2026 to its intellectual property relating to BRYHALI Lotion in the United States.

Glenmark acknowledges the validity of the licensed patents. Final patent expiry on BRYHALI Lotion is 2031.

Under the terms of the agreement, beginning 2026 (or earlier under certain circumstances), Glenmark will have the option to market a royalty-free generic version of BRYHALI Lotion, should it receive approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application.

The parties have agreed to dismiss all litigation related to BRYHALI Lotion, and all intellectual property protecting BRYHALI Lotion remains intact. Bausch Health remains confident in the strength of the BRYHALI Lotion patents, and we will continue to vigorously defend its intellectual property.

About Ortho Dermatologics
Ortho Dermatologics is one of the largest prescription dermatology businesses dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio includes several leading acne, anti-fungal and corticosteroid-responsive dermatoses products. More information can be found at www.ortho-dermatologics.com.

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.

Forward-looking Statements 
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.

1Loss of exclusivity may be earlier under certain circumstances.

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SOURCE Bausch Health Companies Inc.