In what will be a big boost for pharma major Dr. Reddy’s Laboratories Ltd., in the ongoing legal battle for launching a generic version of Indiviors opioid dependence treatment drug Suboxone, the U.S. Court of Appeals for the Federal Circuit has denied the British drugmaker plea for a rehearing.
The U.S. Court of Appeals for the Federal Circuit has denied Indivior’s motion for rehearing and rehearing en banc following the December ruling vacating the preliminary injunction granted against Dr. Reddy’s Laboratories. The court also said the mandate is set to be issued on February 11, 2019, the British drugmaker informed LSE on Tuesday.
Dr.Reddy’s was yet to issue a statement. The company’s shares were being traded at ₹2,810 apiece around 3.30 p.m. an increase of 2.48% after hitting a high of ₹2,857.55 intra-day.
Once the court issued the mandate, Dr. Reddy’s will “no longer be prevented from selling, offering to sell, or importing its generic buprenorphine/naloxone sublingual film product in the US,” Indivior said. The mandate is a formal order by the CAFC that returns the case to the District Court for actions consistent with its ruling.
Indivior assumes DRL will resume the launch of its generic buprenorphine/naloxone sublingual film product in the U.S. once the CAFC issues the mandate. It also assumes that Alvogen Pine Brook LLC will also launch its generic, pursuant to a January 31, 2019 agreement between Alvogen and Indivior.
According to the British drugmaker, the launch in the U.S. of a generic product that can be directly substituted by a pharmacist for the branded product without consultation with the patient would result in the branded incumbent (in this case Suboxone) losing up to 80% of its market share within a matter of months.
Indivior, however, said it intends to file an emergency motion with the CAFC to stay issuance of the mandate pending resolution of the company’s appeal of the District of Delaware’s decision finding DRL does not infringe the U.S. Patent of the drug. Indivior’s has also filed petition for a writ of certiorari to the Supreme Court of the United States in the preliminary injunction matter.
“We are disappointed that the CAFC has denied Indivior’s motion for rehearing,” said Shaun Thaxter, CEO of Indivior.
“While we ultimately believe in the strength of our patent portfolio, we acknowledge the company faces major disruption in the immediate future from a potential material and rapid loss of market share by our Suboxone film product to generic buprenorphine/naloxone sublingual film competition,” he said.