After two-year patent infringement litigation with Dr. Reddy’s, Teva, and Mylan, the US Court of Appeals for the Federal Circuit concluded that Dr. Reddy’s had not infringed on Indivior’s patent.
The Federal Circuit Court’s decision vacated the preliminary injunction that prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone), an opioid use disorder treatment, and opened a path for generics.
Dr. Reddy’s resumed shipping its product which was approved by the US Food and Drug Administration (FDA) in June, 2018 and was immediately launched. The temporary restraining order and preliminary injunction put on Dr. Reddy’s by Indivior did not prohibit commercial manufacturing of the product and production continued.
Shaun Thaxter, CEO of Indivior, said in a statement, “We are making an authorized generic of 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.”
Additionally, in December, Indivior stated its intentions for launching a cheaper version of the drug as part of a multi-phase contingency plan to avoid market share losses from generic rivals.
Novartis’ subsidiary Sandoz will market and distribute the generic on behalf of Indivior.
Shortly after Indivior announced the launch of its generic, Mylan made a statement regarding the release of its generic including that the US Food and Drug Administration (FDA) gave the product’s Abbreviated New Drug Application (ANDA) its final approval.
Since June 2018, Indivior’s shares have fallen around 80% after Dr. Reddy’s and Mylan’s generics were approved.
Indivior’s own generic is expected to make tens of millions of dollars in revenue, according to the company.
According to IQVIA, in 2018, US sales for buprenorphine and naloxone sublingual film were approximately $1.87bn (€1.65bn). After the US declared opioid abuse a public health emergency, the market for opioid use disorder therapies will continue to see growth.