Ruling revives launch of Dr. Reddy’s generic Suboxone sublingual film
Dr. Reddy’s will resume its launch of generic Suboxone sublingual film, an opioid treatment drug, following a ruling by the United States Court of Appeals for the Federal Circuit in favor of the company.
The ruling concluded that Indivior had not shown that it is likely to succeed on the merits of its infringement case on U.S. Patent No. 9,931,305.
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.
“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 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 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. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order against Dr. Reddy’s.
The TRO did not include a prohibition on commercial manufacturing of the product.
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