Dr Reddy's to appeal restriction on sale of generic Suboxone film in US
New Delhi: Pharma major Dr Reddy's Laboratories said it will appeal the decision of the US District Court of New Jersey regarding further sales and commercialization of its Buprenorphine and Naloxone sublingual film in America.
"The company disagrees with the court's decision, and will vigorously appeal it," Dr Reddy's said in a BSE filing.
The company intends to appeal the decision made by the US District Court of New Jersey in a preliminary injunction hearing with respect to further sales and commercialization of its product in the US, it added.
The Hyderabad-based firm had announced the receipt of approval by one of its wholly-owned subsidiaries from the US Food and Drug Administration (USFDA) on June 15, 2018, Dr Reddy's said.
The approval was for the company's Buprenorphine and Naloxone sublingual film in various strengths for the US market. It is the generic version of Indivior UK's Suboxone sublingual film.
The product is indicated for the treatment of opioid dependence.
The move was taken after a U.S. court has granted Indivior a preliminary injunction blocking Dr Reddy’s Laboratories from selling cut-price versions of the British drugmaker’s best-selling opioid addiction treatment in the United States.
Indivior, a maker of opioid addiction treatments spun-off from Reckitt Benckiser in 2014, has been involved in a number of legal battles with generic drugmakers over their versions of its Suboxone Film.
Indivior got a temporary restraining order against Dr Reddy’s in June, but the British firm saw the impact from a generic in the market as Suboxone’s market share dropped rapidly by 2.5 percent to 52 percent.
Indivior said the restrictions of the previous restraining order remain in place, preventing Dr. Reddy’s from selling or importing its generic buprenorphine/naloxone sublingual film product.
Dr. Reddy’s and U.S.-based Mylan NV got approval from the Food and Drug Administration (FDA) last month to sell versions of Indivior’s bestselling opioid addiction treatment, which followed an immediate generic launch by the Indian firm in June.
Friday’s court ruling prevents Dr. Reddy from re-launching its generic product until the patent litigation is concluded or until the company prevails on an appeal of the injunction.
“While we do not know the timing for these events, we will continue to vigorously defend our intellectual property,” Indivior Chief Executive Officer Shaun Thaxter said.
The ruling comes days after Indivior scrapped its full-year guidance citing an “accelerated” loss in U.S. market share to the cheaper version of Suboxone launched by Dr. Reddy’s.
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