US court restrains Dr Reddy's from selling generic de-addiction drug Suboxone

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26 Aug, 2025 12:21

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Dr Reddy’s, on Saturday, received from the US District Court of New Jersey a restraining order on selling generic version of Suboxone in the US market.

Suboxone is used for the treatment of opioid dependence

Dr. Reddy's launched its generic buprenorphine/naloxone sublingual film product "at-risk" in the US on Friday after it got final approval from USFDA.

Indivior, the innovator, which was spun out from British drug maker Reckitt Benckiser said it will pursue all legal remedies available to it, including seeking an immediate injunction.

Suboxone brand had US sales of around USD 1.86 billion for the 12 months ended April 2018, according to IQVIA. The drug contributes about 80 percent of Indivior sales. Shares of Indivior were down 22.7 percent on the FTSE midcap index.

“Following the launch of generic Buprenorphine and Naloxone Sublingual Film in the US market, the US District Court for the District of New Jersey has received and reviewed an emergency application from the plaintiffs (Indivior) in the current patent litigation for a temporary restraining order and preliminary injunction against Dr Reddy’s,” the company said in a statement to stock exchanges.

“The court order does not include a prohibition on commercial manufacturing of the product. The plaintiffs will be required to post a bond or other security totaling USD 18 million to satisfy any losses or damages incurred by Dr Reddy’s during the period of the temporary restraining order,” the Hyderabad-based drug maker added.

The court has scheduled an expedited hearing of the preliminary injunction on June 28, and a ruling is expected soon thereafter.

The proceeding only involves one patent, US Patent No. 9,931,305.

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.

Analysts say generic Suboxone is a substantial opportunity for Dr Reddy's which was struggling to get quality approvals for the last three years with key plant under warning letter.

"It is going to be at-risk launch for Dr Reddy as litigation yet to be settled. Essentially, it means if litigation goes against Dr Reddy's they have to return the profits generated from this product to innovator," said Amey Chalke, pharma analyst at HDFC Securities.

Chalke said the product could add Rs 14 eps for Dr Reddy's, if it is allowed to get marketed.