The U.S. District Court for the District of New Jersey has granted a preliminary injunction against Dr. Reddy’s Laboratories Ltd. preventing Dr. Reddy’s from selling, offering to sell, or importing its generic version of Indivior PLC‘s buprenorphine/naloxone sublingual film product, Suboxone Film.
Dr. Reddy’s announced its intention to “vigorously appeal” the court decision. The U.S. Food and Drug Administration on June 15 had approved Dr. Reddy’s therapeutic-equivalent generic version of Suboxone Film—2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg.
The latest move by the court keeps in place restrictions of the previously entered temporary restraining order pending the outcome of recently filed litigation against Dr. Reddy’s related to U.S. Patent No. 9,931,305—otherwise referred to as the ‘305 patent)—or a decision of the U.S. Court of Appeals for the Federal Circuit dissolving the injunction. The court also ordered the parties to submit a final proposed injunction order on Monday.
As part of the preliminary injunction, the District Court also ordered Indivior to post a bond to provide security to Dr. Reddy’s should the court conclude at the end of patent litigation that the ‘305 patent is invalid and/or not infringed. The bond amount will be determined by the court at a later date.
According to Indivior, Dr. Reddy’s sold an unknown quantity of its generic buprenorphine/naloxone sublingual film into the U.S. market prior to the granting of the temporary restraining order in June, but based on recent abrupt loss of Suboxone Film market share, Indivior expects a fiscal year 2018 net revenue impact to be at least $25 million.
Partly based on that, Indivior said its financial guidance for the fiscal year is no longer valid and that “it cannot reliably provide updated FY 2018 net revenue and adjusted net income guidance until the impact of (Dr. Reddy’s) launch is better understood,” expected by its Q3 results announcement, currently scheduled for November 1.
The court’s decision does not prevent patients or payors from accessing existing generic sublingual buprenorphine/naloxone medications, since all currently available treatments are unaffected by the preliminary injunction ruling, according to Indivior.
But, the company cautioned that patients may face other challenges accessing treatment, such as difficulty finding a treatment provider or dealing with the stigma associated with addiction.