The US District Court of New Jersey granted a temporary restraining order (TRO) preventing Alvogen from launching any activities related to its buprenorphine/naloxone sublingual film.
Alvogen’s buprenorphine/naloxone sublingual film is a generic version of Indivior’s Suboxone (buprenorphine/naloxone) sublingual film, a treatment for substance use disorder which Aquestive and Indivior have a patent on.
This TRO will remain in place pending the outcome from a previous preliminary injunction filed by Aquestive and Indivior. The hearing for the injunction is scheduled for February 7, 2019.
Keith Kendall, CEO of Aquestive Therapeutics, said in a statement that the company is pleased that the court granted its request for a temporary restraining order, as the company and Indivior work to “assert and protect [its] intellectual property embedded in Suboxone.”
Suboxone sales account for 80% of Indivior’s revenue and competing generics from both Alvogen and Dr. Reddy’s are set at lower price points.
Aquestive and Indivior’s 305 patent for Suboxone is the subject of multiple patent infringement litigation cases regarding buprenorphine/naloxone sublingual films
Indivior and Aquestive litigation over its Suboxone patent with Dr. Reddy’s is also ongoing. As of December 2018, the District Court of New Jersey overturned the preliminary injunction against Dr. Reddy’s granting the generic company the right to sell its buprenorphine/naloxone sublingual film. However, Dr. Reddy’s petitioned the court to stay the injunction until an official mandate was issued.