(Reuters) - A U.S. court has granted Indivior a preliminary injunction blocking India’s Dr. Reddy’s Laboratories from selling cut-price versions of the British drugmaker’s best-selling opioid addiction treatment in the United States, Indivior said on Friday.
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 on Friday 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.
Reporting by Justin George Varghese and Nivedita Balu in Bengaluru; Editing by Patrick Graham, Diane Craft and Cynthia Osterman