Indivior Announces Ruling by the Court of Appeals for the Federal Circuit in ANDA Litigation
Slough, UK, July 15, 2019 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that the Court of Appeals for the Federal Circuit (CAFC) has affirmed the judgments of the U.S. District Court for the District of Delaware (the “District Court”) finding that Watson Laboratories Inc. (Watson); Dr. Reddy’s Laboratories (DRL); and Alvogen Pine Brook, LLC (“Alvogen”) failed to show that the asserted claims of U.S. Patent No. 8,603,514 (the “‘514 Patent”) related to SUBOXONE® (buprenorphine and naloxone) Film are invalid, but that the asserted claims are not infringed by DRL and Alvogen. The CAFC also affirmed the judgments that DRL failed to provide that the asserted claims of U.S. Patent No. 8,017,150 (the “‘150 Patent”) related to SUBOXONE® Film are invalid, but that those claims are not infringed by DRL. Alvogen and DRL have been marketing their generic buprenorphine/naloxone sublingual film products at-risk since February 2019. The CAFC also upheld the District Court’s decision that Watson (now known as Actavis Laboratories UT, Inc.) infringes the ’514 Patent. Therefore, Watson/Actavis remains enjoined from launching their generic buprenorphine/naloxone sublingual film product until the expiration of the ’514 Patent on April 3, 2024.
About Indivior
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment
models that have revolutionized modern addiction treatment. The name is the fusion of the
words individual and endeavour, and the tagline “Focus on you” makes the Company’s
commitment clear. Indivior is dedicated to transforming addiction from a global human
crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid
dependence treatments, Indivior has a strong pipeline of product candidates designed to
both expand on its heritage in this category and address other chronic conditions and cooccurring disorders of addiction, including alcohol use disorder and schizophrenia.
Headquartered in the United States in Richmond, VA, Indivior employs more than 800
individuals globally and its portfolio of products is available in over 40 countries worldwide.
Visit www.indivior.com to learn more.
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Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com