Express Pharma

DRL re-launches Buprenorphine and Naloxone Sublingual Film in US

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The re-launch comes on the heels of a favourable decision issued by the United States Court of Appeals for the Federal Circuit

Dr Reddy’s Laboratories (DRL) has re-launched its Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the US market.

The re-launch comes on the heels of a favourable decision issued by the United States Court of Appeals for the Federal Circuit concluding that Indivior had not shown that it is likely to succeed on its claim that DRL product infringes US Patent No 9,931,305. The Federal Circuit’s decision vacates the District Court’s preliminary injunction that had prohibited DRL from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. The Federal Circuit’s decision went into effective yesterday. As a result of the Federal Circuit’s ruling, DRL has resumed shipping of the product.

“We are pleased with the decision of the appellate court in DRL favour, vacating the preliminary injunction that had prevented DRL from continuing to market this important drug to the public,” explains Marc Kikuchi, CEO, North America Generics. “DRL is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the US who are impacted by the opioid epidemic.”

In June 2018, the US Food and Drug Administration (US FDA) approved Dr Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialisation activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against DRL. The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.

 

 

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