Indivior Preliminary Injunction on Generic (buprenorphine and naloxone) Sublingual Film Upheld
- Company will continue to vigorously defend our SUBOXONE® (buprenorphine and naloxone)
Sublingual Film intellectual property -
Slough, UK, 31 July 2018 – Indivior PLC (LON: INDV) (Indivior or the Company) today announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) has denied Dr. Reddy’s Laboratories’ (DRL’s) motion for a stay of the July 13, 2018 preliminary injunction (PI) previously granted by the District of New Jersey. The PI prohibits DRL from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product. DRL appealed this ruling, and filed emergency motions seeking to expedite the appeal of the PI, and to stay the PI pending a ruling on appeal. Today’s ruling means that DRL continues to be prohibited from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product pending a favorable outcome for DRL on its appeal of the PI, or the District of New Jersey litigation related to U.S. Patent No. 9,931,305 (the ‘305 Patent); 9,687,454 (the ’454 Patent); and 9,855,221 (the ’221 Patent). The CAFC previously granted DRL’s motion to expedite the appeal, and oral argument will be held the first week of October 2018.
Indivior will continue to vigorously defend its patent rights to SUBOXONE®Film, including opposing DRL’s PI appeal, and continuing to pursue the appeal of the District of Delaware’s noninfringement ruling related to U.S. Patent No. 8,603,514 (the ’514 Patent), and the recently filed litigation asserting the ’305, ’454, and ’221 Patents in the District of New Jersey.
Corporate Website
www.indivior.com
This announcement 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
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 co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 1000 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 announcement 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 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 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.
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