Victory for Dr Reddy’s! US court allows sell of generic suboxone
In a major relief to a patent litigation, a US court has allowed Dr. Reddy’s Laboratories to sell a generic version of the UK-based Indivior opioid treatment Suboxone sublingual film.
In a major relief to a patent litigation, a US court has allowed Dr. Reddy’s Laboratories to sell a generic version of the UK-based Indivior opioid treatment Suboxone sublingual film. The United States Court of Appeals for the Federal Circuit has issued a decision in favour of Dr. Reddy’s Laboratories, concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case.
This 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. As a result of this ruling, Dr. Reddy’s will resume its launch activities as soon as permitted.
“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 bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and in particular look forward to taking the lead in helping to fight Opioid Use Disorder,” a company spokesperson said.
In June, 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 commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) against Dr. Reddy’s. The TRO did not include a prohibition on the commercial manufacturing of the product.
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