Indivior Announces Launch of SUBOXONE® (buprenorphine and naloxone) Sublingual Film Authorized Generic

Slough, UK and Richmond, VA, 20 February 2019 – Indivior PLC (LON: INDV) today announced that its U.S. affiliate, Indivior Inc., has launched an authorized generic version of SUBOXONE® (buprenorphine and naloxone)  Sublingual Film (CIII) in the U.S. The authorized generic is being marketed and distributed on Indivior’s behalf by Sandoz Inc.

This business decision is based on the market impact expected from the anticipated “at risk” launch of a generic buprenorphine and naloxone sublingual film product in the U.S. by Dr. Reddy’s Laboratories (“DRL”) and/or Alvogen Pine Brook LLC (“Alvogen”).

On February 19, the Supreme Court of the United States denied Indivior’s motion to stay issuance of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) mandate vacating the Preliminary Injunction (PI) granted against DRL. The CAFC subsequently issued the mandate vacating the PI granted against DRL. The U.S. District Court for the District of New Jersey then issued orders dissolving the temporary restraining order against Alvogen and confirming the PI against DRL had been vacated. DRL and Alvogen therefore are no longer prevented from selling, offering to sell, or importing their generic buprenorphine/naloxone sublingual film products.

Any DRL and Alvogen generic product sales in the U.S. will be on an “at-risk” basis, subject to the outcome of the CAFC appeal of the judgments related to U.S. Patent No. 8,603,514, (and U.S. 8,017,150 in the case of DRL), as well as ongoing litigation in the District of New Jersey asserting Orange Book-listed U.S. Patent Nos. 9,931,305 and 9,687,454.

Shaun Thaxter, Chief Executive Officer of Indivior, said, “We are making an authorized generic of our SUBOXONE® Film brand product available to patients and providers immediately, giving them yet another option of medication-assisted treatment for opioid dependence. In addition, we expect this launch will create the opportunity to maximize the value of our SUBOXONE® Film franchise.”

With the launch of this authorized generic by Indivior, it is possible that other companies may also launch their own generic versions of SUBOXONE® Film.

As the current leading provider of buprenorphine medication-assisted treatment in the U.S., Indivior is committed to realizing its Vision that all patients around the world have access to evidence-based treatment for the chronic condition and co-occurring disorders of addiction.

SUBOXONE® Film is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

About Opioid Use Disorder (OUD)
Opioid use disorder (OUD), sometimes referred to as opioid addiction, is a chronic disease1 . According to DSM 5, “OUD is characterized by signs and symptoms that reflect compulsive, prolonged selfadministration of opioid substances that are used for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, they are used in doses greatly in excess of the amount needed for that medical condition2 .”

Based on 2016 data from the National Survey on Drug Use and Health report, approximately 11.8 million Americans (age 12+ years) engaged in misuse of opioids in the past year3 . From 1999 to 2016, the rate of deadly prescription opioid overdoses increased five-fold4 . In 2016, an average of 115 people died of opioid overdose each day in the United States5 . In addition, in 2016, 935,000 adults used heroin and approximately 625,000 adults had a heroin use disorder3 . In 2015, opioids accounted for 70 percent of the disease burden associated with drug use disorders worldwide6

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.
 

Forward thinking 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 6 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 because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2019 and its medium- and long-term 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.

This press release does not constitute an offer to sell or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

Media Contacts

US
IndiviorMediaContacts@indivior.com
+1 804-594-0836

UK
Tulchan Communications
+44 207-353-4200

Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com