Slough, UK, 15 June 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that it is aware that, on 14 June 2018, the US FDA approved generic versions of SUBOXONE® Film from both Dr. Reddy’s and Mylan, and that Dr. Reddy’s subsequently announced it has launched its generic buprenorphine/naloxone sublingual film product “at-risk” in the US.
Indivior notes that such an “at-risk” launch by Dr. Reddy’s is a result of ongoing patent litigation between the parties, including Indivior’s appeal of the finding of non-infringement of US Patent No. 8,603,514 and the assertion of three recently-granted Orange Book-listed patents (US 9,687,454, US 9,855,221 and US 9,931,305 patents). As a consequence, Indivior will pursue all legal remedies available to it, including seeking an immediate injunction.
Although it is not possible to quantify precisely the financial impact that the launch of generic alternatives to SUBOXONE® Film would have on Indivior’s revenues generated from SUBOXONE® Film in the US, or how quickly such an impact would take effect, the Company believes that it could potentially result in a rapid and material loss of market share for SUBOXONE® Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market.
As previously noted, Indivior has developed detailed contingency plans to be brought into effect in the event of actual market entry by Dr. Reddy’s. These include the potential launch of an authorized generic as well as defined operational cost savings measures. An overriding principle of these plans is to continue to support and optimize the launch of SUBLOCADE™, the Company’s novel monthly buprenorphine extended-release injection for moderate to severe opioid use disorder.
Until the details of Dr. Reddy’s market entry are confirmed, Indivior’s guidance for 2018 remains unchanged. However, the company’s guidance was issued on the basis of no material change in market conditions. In the event of market entry by Dr. Reddy’s, the Company will revisit its guidance in light of the changed market circumstances.
Shaun Thaxter, CEO of Indivior, said:
“We are surprised by Dr. Reddy’s decision to launch “at risk” given the ongoing litigation and associated significant risk to them of substantial economic damages if, as we believe, we eventually prevail in protecting the SUBOXONE® Film patent estate. In the meantime, we will continue to pursue all legal avenues, including an immediate injunction until the legal status of our intellectual property is confirmed by the Courts.”
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
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