Dr Reddy’s Laboratories Ltd has re-launched its Buprenorphine and Naloxone Sublingual Film, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States market.
The re-launch comes on the heels of a favorable 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 Dr Reddy’s product infringes US Patent No 9,931,305, Hyderabad-based pharmaceutical company said in a statement here on Wednesday.
The Federal Circuit’s decision vacates the District Court’s preliminary injunction that had prohibited Dr Reddy’s 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, Dr Reddy’s has resumed shipping of the product.
The decision of the appellate court in Dr Reddy’s favor, vacating the preliminary injunction that had prevented Dr Reddy’s from continuing to market this important drug to the public,” said North America Generics Chief Executive Officer (CEO)Marc Kikuchi.
Dr Reddy’s is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the United States who are impacted by the opioid epidemic, the CEO added.
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 manufacturing of the product.(UNI)
