Dr. Reddy's Suboxone sublingual film faces legal hurdle

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Dr. Reddy's Suboxone sublingual film faces legal hurdle

Not long after receiving approval for its generic Suboxone sublingual film from the Food and Drug Administration, Dr. Reddy’s has been blocked from selling it. The U.S. District Court for the District of New Jersey on Friday issued a temporary restraining on the company’s launch activities.

The temporary restraining order was granted ahead of a June 28 hearing regarding a preliminary injunction filed by Suboxone sublingual film maker Indivior. The Slough, U.K.-based company is looking to extend the block on launch activities as it awaits the outcome of an appeal it filed surrounding a patent relating to the Suboxone sublingual film.

“We are pleased that the Court has granted our request for a temporary restraining order. This order will stop Dr. Reddy’s launch activities before the court has had a chance to rule on the preliminary injunction motion,” Indivior CEO Shaun Thaxter said. “We will continue to pursue all legal avenues against Dr. Reddy’s to protect our Subxone Film patent estate.”

Dr. Reddy’s has defended its ability to launch its generic, and noted that the temporary restraining order does not include a prohibition on commercial manufacturing of the product. It also said that it expects Indivior to post a bond or other security of $18 million to satisfy any losses or damages it incurs while the order is in place.

“Dr. Reddy’s remains confident in its legal positions on this patent and believes it will prevail on the issues raised with respect to the application for injunction,” the company said.

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