Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, has announced its intent to appeal a preliminary injunction made by a federal US district court against further sales and commercialization of Dr. Reddy’s buprenorphine and naloxone sublingual film within the US, a drug for treating opioid dependence.

The US District Court for the District of New Jersey has granted a preliminary injunction against Dr. Reddy’s Laboratories. The decision follows a move (June 2018) in which the district court granted Indivior, a Slough, UK-headquartered pharmaceutical company, a temporary restraining order (TRO) that compelled Dr. Reddy’s Laboratories to immediately cease launch activities related to its generic version of Indivior’s Suboxone Film (buprenorphine and naloxone). The restrictions of the previously entered TRO remain in place, and Dr. Reddy’s Laboratories is unable to sell, offer to sell, or import its generic buprenorphine/naloxone sublingual film product in the US.

“The company disagrees with the court’s decision and will vigorously appeal it,” the company said in a July 14, 2018 company statement.

The US Food and Drug Administration (FDA) approved the first two generic versions of Indivior’s Suboxone sublingual (under the tongue) film to Dr. Reddy’s and Mylan in June 2018. The Suboxone brand had US sales of approximately $1.86 billion for the 12 months ending in April 2018, according to information from IQVIA (formerly IMS Health) and as reported by Dr. Reddy’s Laboratories.

Dr. Reddy’s launched the product “at risk,” according to information from Indivior. An “at-risk” generic drug launch occurs when a company launches a generic drug into the market while patent litigation is still ongoing. Indivior and Mylan came to an agreement in September 2017 to resolve patent litigation related to Suboxone.

Source: Dr. Reddy’s Laboratories and Indivior