Indivior trusts its portfolio, aware of challenges for Suboxone

Indivior PLC said Wednesday said in a statement it is dissapointed by the US District Court for the District of New Jersey vacating a preliminary injunction againste Dr.Reddy’s Laboratories which had prevented DRL from selling its generic buprenorphine/naloxone sublingual film product.

Indivior said that DRL will resume the launch of its generic buprenorphine/naloxone sublingual film product in the U.S, without the exact timing for DRL’s potential U.S. market re-entry
Indivior said it will oppose DRL’s motion and file a petition for both panel rehearing and rehearing en banc of the ruling vacating the PI.

According to Indivior’s announcement, its FY 2018 guidance for net revenue of $990-$1,020m and net income of $230-255m, which was issued on September 26th and confirmed on November 1st, was based on no material changes in current market conditions in the U.S, the company said in its press release. As such, the current FY 2018 guidance remains valid unless there is certainty of generic buprenorphine/naloxone sublingual film entry in 2018, in which case there would be risk to FY 2018 guidance.

Indivor warned in its announcement that the magnitude of the risk will depend upon the timing of any generic entry. The company said that, if th egeneric buprenorphine/naloxone sublingual film enters the market in 2018, the result can be a rapid and material loss of market share for Suboxone (buprenorphine and naloxone) Sublingual Film.

Indivior’s CEO Shaun Thaxter, said: “While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces challenges in the intervening period resulting from a potential material and rapid loss of market share to generic buprenorphine/naloxone sublingual film competition, including reduced earnings and cash flow. As the current leading provider of buprenorphine-based medication-assisted treatment (BMAT) in the U.S., Indivior is committed to continuing to realize its Vision that all patients around the world have access to evidence-based treatment for the chronic condition and co-occurring disorders of addiction. The company is in advanced stages of contingency planning. In light of the timing of this judgement, we will now undertake a full review of our plans and will update the market on the Company’s path forward as soon as practicable. “

He added that the company will continue to vigorously pursue its infringement cases against DRL to protect its Suboxone Film patent portfolio, including filing a petition with the CAFC for both panel rehearing and rehearing en banc of the ruling vacating the PI, as well as opposing DRL’s motion to immediately issue a mandate or stay the current PI until the mandate is issued.