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Dr Reddy’s Laboratories has received a favourable judgment in a litigation pertaining to Suboxone (buprenorphine and naloxone) sublingual film in a US court.
The United States Court of Appeals for the Federal Circuit issued a decision in favor of Dr Reddy’s Laboratories Inc concluding 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.
As a result of today’s ruling, Dr Reddy’s will resume its launch activities as soon as permitted.
A company spokesperson stated, “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.
In June, the US Food and Drug Administration (USFDA) approved Dr. Reddy’s Buprenorphine and Naloxone Sublingual Film for sale in the U.S. 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) against Dr. Reddy’s. The TRO did not include a prohibition on commercial manufacturing of the product.
The Hyderabad-based company's scrip zoomed 6.45 per cent on the Bombay Stock Exchange on Wednesday after the announcement and is trading at Rs 2605.45.
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