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Dr Reddy’s Laboratories Ltd has said it has re-launched its Buprenorphine and Naloxone Sublingual Film, generic version of Suboxone, in the US market.
According to a press release issued by the city-based drug maker on Wednesday night, the re-launch comes on the heels of a favourable decision delivered by the US Court of Appeals for the Federal Circuit, concluding that UK-based Indivior had not shown that it is likely to succeed on its claim that Dr Reddy’s product infringes a patent pertaining to Suboxone.
Indivior is in a legal battle against the launch of the copycat version of its opioid addiction treatment by competitors, including Dr Reddy’s Laboratories, in the US market.
Suboxone had sales of around $1.86 billion in the US for the 12 months ended April 2018, according to market reports.
“We are pleased with the decision of the appellate court in Dr Reddy’s favour, vacating the preliminary injunction that had prevented Dr Reddy’s from continuing to market this important drug to the public,” Marc Kikuchi, Chief Executive Officer, North America Generics of DRL, said.
In June 2018, the US Food and Drug Administration (USFDA) 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 Dr Reddy’s.
The TRO and preliminary injunction did not prohibit commercial manufacture of the product.
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