Dr. Reddy’s Laboratories moved one step closer to resuming sales of its generic version of Indivior’s opioid dependence treatment drug Suboxone with the U.S. Court of Appeals for the Federal Circuit (CAFC) turning down the British drug maker’s plea to stay issuance of the mandate in a case between the two companies.
“The U.S. Court of Appeals for the Federal Circuit [has] denied Indivior’s motion to stay issuance of the mandate following the CAFC’s ruling vacating the preliminary injunction granted against Dr. Reddy’s Laboratories,” Indivior said in a regulatory filing to the London Stock Exchange on Tuesday.
The preliminary injunction (PI) was granted in a patent case pertaining to Suboxone. On February 11, while denying Indivior’s motion for a stay, the court also ordered that the mandate be issued on February 19.
Indivior said it would file a petition to stay the mandate with the Supreme Court of the United States.
Post the court ruling, vacating the PI, Indivior’s had filed a motion for rehearing en banc, which too was denied by the court earlier this month. The issue of the mandate is important as it is a formal filing by which the CAFC returns the case to the district court for action consistent with its ruling.
Once the mandate is issued, Dr.Reddy’s Laboratories as well as Alvogen Pine Brook LLC, which also has a generic version of Suboxone, “will no longer be prevented from selling, offering to sell or importing their generic buprenorphine/naloxone sublingual film product.” Stating this, Indivior said it assumed DRL and Alvogen would launch their respective generic version as soon as CAFC issued the mandate.
Any DRL and Alvogen generic product sales in the U.S., however, would be on an “at-risk” basis, subject to the outcome of court cases pertaining to the patents related to Suboxone.
Indivior had earlier said the launch in the U.S. of a generic product that could be directly substituted by a pharmacist for the branded product without consultation with the patient would result Suboxone losing up to 80% of its market share within a matter of months.
Dr.Reddy’s shares gained 1.17% or ₹30.55 apiece to close at ₹2,647.50 each. It touched an intra-day high of ₹2,674.40. The Hyderabad-headquartered pharma major, however, was yet to issue a statement in the matter pertaining to court decision in Suboxone case.
