Indivior Enters into Settlement with Par Pharmaceutical in Patent Infringement Case
Slough, UK, May 14, 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that its U.S. subsidiary, Indivior Inc., together with Aquestive Therapeutics, Inc. (formerly known as Monosol Rx, LLC), entered into a settlement agreement with Par Pharmaceutical Inc., Par Pharmaceutical Companies Inc., Endo International PLC (collectively, “Par”) and IntelGenx Technologies Corp., resolving patent litigation related to SUBOXONE® (buprenorphine and naloxone) Sublingual Film. The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Par’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration seeking approval to market generic versions of SUBOXONE® Film. The settlement permits Par to begin selling a generic version of SUBOXONE® Film on January 1, 2023, or earlier under certain circumstances. Other terms of the settlement are confidential.
As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Shaun Thaxter, CEO of Indivior, said, “We are pleased to have amicably settled another piece of outstanding patent infringement litigation. We continue to seek greater certainty for Indivior, but on terms that adequately reflect the strength of our intellectual property, including the three new Orange Book patents that have been asserted against the remaining ANDA filers.”
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. Our vision is for all patients around the world to have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. The name is the fusion of the words individual and endeavor, 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 co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.Indivior.com to learn more.
Forward-Looking Statements
This press release contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements 2 because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2018 and its medium- and longterm growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation.
Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group’s products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group’s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group’s products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group’s ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group’s products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.
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Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com