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U.S. court decision delays Dr. Reddy’s Suboxone sale

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Pharma major’s shares fall 4.7% to ₹2,582 apiece

Dr. Reddy’s Laboratories shares down 4.69% to ₹2,582 on Wednesday from ₹2,709 on Tuesday in the wake of a U.S. court decision that is likely to extend its wait to resume sale of a generic version British drug maker Indivior’s opioid dependence treatment drug Suboxone.

“The U.S. Court of Appeals for the Federal Circuit (CAFC) has denied Dr. Reddy’s Laboratories, motion to immediately issue the mandate following the CAFC’s ruling vacating the preliminary injunction (PI),” Indivior said in a filing with the LSE.

The CAFC had last month vacated the District Court’s preliminary injunction that prohibited Dr. Reddy’s from selling the generic version of Suboxone (buprenorphine and naloxone) sublingual film. In its intimation to the stock exchange, Indivior said the mandate was a formal filing by the CAFC that returned the case to the District Court for action consistent with its ruling. The CAFC also ordered that any petition for re-hearing must be submitted on or before December 20, 2018.

Injunction to stay

“As a result of the ruling, thep CAFC will not immediately issue the mandate, meaning that the PI will remain in place and DRL will remain enjoined from resuming their “at-risk” launch in the U.S. market of its generic buprenorphine-naloxone sublingual film until after the mandate issues,” Indivior said. The firm would file for re-hearing and rehearing en banc by December 20. and the court must rule on the petition before the mandate can be issued, the filing said.

The Hyderabad-headquartered pharma major’s shares closed at ₹2,582.10 each, a decline of ₹127.10 from the previous close.

Indivior CEO Shaun Thaxter said the company would continue to “vigorously pursue our infringement cases against DRL to protect our Suboxone.”

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