Dr. Reddy’s To Get $72-Million Settlement Pay In Opioid Patent Dispute
The Indian drugmaker will receive payments worth $72 million (around Rs 560 crore) by March 31, 2024.
Dr. Reddy’s Laboratories Ltd. has reached a settlement with Indivior Inc. in a patent dispute over its generic of an opioid addiction treatment.
The Indian drugmaker will receive payments worth $72 million (around Rs 560 crore) by March 31, 2024, its exchange filing said, as compensation for the lost U.S. sales of the generic. The agreement resolves all claims between the parties relating to buprenorphine and naloxone sublingual film—the copycat version of Suboxone Film, jointly developed by Indivior and Aquestive Therapeutics, Inc.—including the patent infringement allegations and antitrust counterclaims.
“As part of the settlement, the underlying litigation will be dismissed.”
Dr. Reddy’s launch of the generic of Suboxone Film was delayed on account of a court injunction in 2018, even as it received a regulatory approval earlier to sell the product for treating opioid dependence.
On June 14, 2018, the U.S. Food and Drug Administration had granted a final approval to Dr. Reddy’s for the product. That was after the U.S. District Court for the District of Delaware held that the patents covering Suboxone Sublingual Film would not be infringed by the commercial launch of its generic.
On June 15, 2018, Indivior filed a second lawsuit against Dr. Reddy’s alleging infringement of three additional U.S. patents and an emergency application for a temporary restraining order and preliminary injunction in the New Jersey District Court. It, however, ruled in favour of the Indian drugmaker in 2019.
That allowed Dr. Reddy’s to resume sales of the drug. But since then, the litigation has been ongoing.
Dr. Reddy’s, in its 2021 annual report, had disclosed that it intended to vigorously defend its positions and pursue a claim for damages caused by the preliminary injunction. “Any liability that may arise on account of this litigation is unascertainable. No provision was made in these consolidated financial statements of the company”.
“On the prescription side, this product may be one of the largest products of Dr. Reddy’s in the U.S.,” Vishal Manchanda, pharma analyst at Systematix, told BQ Prime.
The U.S. contributed 35% to Dr. Reddy’s total sales in FY22.
Dr. Reddy’s stock closed 0.27% higher on Friday compared with the benchmark Sensex’s 0.88% gain.
(Corrects an earlier version that misstated the company’s name in Manchanda’s designation.)
