Dr. Reddy's relaunches generic Suboxone sublingual film

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Dr. Reddy's relaunches generic Suboxone sublingual film

By Sandra Levy - 02/21/2019
Dr. Reddy’s generic Suboxone sublingual film (buprenorphine and naloxone sublingual film) is back on the market. The company made the announcement following a favorable ruling by the United States Court of Appeals for the Federal Circuit, opening the doors to market the generic of Invidior's branded treatment for opioid addiction.

The court concluded that Indivior had not shown that it is likely to succeed on its claim that Dr. Reddy’s product infringes on its patent for the product. The Federal Circuit’s decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic Suboxone sublingual film.

Dr. Reddy's product will be available in dosage strengths of  2 mg buprenorphine/0.5 mg, 4 mg buprenorphine/1 mgnaloxone, 8 mg buprenorphine/2 mgnaloxone and 12 mg buprenorphine/3 mg naloxone. Dr. Reddy’s has resumed shipping the product.

“We are pleased with 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,” Dr Reddy’s North America generics CEO Marc Kikuchi said. “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.”

In June 2018, the FDA approved Dr. Reddy’s buprenorphine and naloxone sublingual film, in four strengths. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order, or TRO and preliminary injunction against Dr. Reddy’s. The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.

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