Market Place
Indivior loses appeal to block generic Suboxone; Dr Reddy’s allowed to market drug
In the US, Indian drugmaker Dr Reddy’s Laboratories (DRL) got a shot in the arm as drugmaker Indivior Plc lost an appeal to block its generic Suboxone opioid treatment. A federal court ruled against Indivior in its bid to stop DRL and Alvogen from selling generic versions of its opioid addiction treatment Suboxone Film.
The federal court upheld lower court rulings that DRL did not infringe two Indivior patents related to Suboxone, and Alvogen did not infringe one of those patents.
Suboxone is an opiate replacement therapy drug used to help treat opiate cravings and withdrawal. It allows opioid-based drug buprenorphine to be absorbed through the mouth to help control cravings and stave off withdrawal. Suboxone Film dissolves to release two active ingredients — buprenorphine and naloxone. When combined with counseling and support services, the therapy is considered one of the most effective ways to treat opioid addiction.
Suboxone Film had accounted for about 80 percent of Indivior’s revenue, until the generic equivalents came in. Indivior had managed to block DRL’s generic version of Suboxone Film through a court injunction in July 2018, despite the Indian company receiving regulatory nod to sell the product. In February this year, the US Supreme Court allowed sale of generic equivalents of Suboxone. Following this, Indivior had appealed against the ruling.
Earlier this year, DRL had sought more than US$ 70 million from Indivior as compensation for lost US sales of its generic version of Suboxone Film.
Last week, Reckitt Benckiser Group Plc, which spun off Indivior in 2014, agreed with US regulators to pay up to US$ 1.4 billion to settle claims.
The settlement, the largest by any company related to the US opioid epidemic, resolved long-running probes by the US Justice Department and the Federal Trade Commission into the companies’ marketing and sales of Suboxone Film.
The deal came after Indivior was indicted and accused in April this year of deceiving doctors and healthcare benefit programs into believing Suboxone Film (which is a form of opioid) was safer and less susceptible to abuse than similar drugs.
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