Dr. Reddy’s Laboratories hopes of resuming sales of its generic version of British drugmaker Indivior’s Suboxone in the U.S. were dashed when a court there restrained it pending outcome in a litigation over the patent of the opioid dependence treatment drug.
A development that is bound to turn the spotlight on Dr. Reddy’s scrip when markets re-open on Monday, the U.S. District Court for the District of New Jersey has granted a preliminary injunction against the Hyderabad-headquartered firm.
Announcing grant of the PI, a July 13 statement issued by Indivior said with it restrictions of the previous temporary restraining order (TRO) remain. DRL would be “unable to sell, offer to sell, or import its generic buprenorphine/naloxone sublingual film product, pending the outcome of recently filed litigation against DRL related to US Patent No. 9,931,305 or a decision of the US Court of Appeals for the Federal Circuit dissolving the injunction.”
Indivior CEO Shaun Thaxter said “as a result of today’s court ruling, Dr.Reddy’s is prevented from re-launching its generic product until the patent litigation related to the ‘305 patent is concluded or until DRL prevails on an appeal of this injunction. While we do not know the timing for these events, we will continue to vigorously defend our intellectual property.”
Responding to the development, Dr.Reddy’s Laboratories on Saturday said “the company disagrees with the court’s decision and will vigorously appeal it.”
The company said in intended to appeal the decision made by the US District Court in a PI hearing with respect to further sales and commercialisation of Dr. Reddy’s Buprenorphine and Naloxone Sublingual film within the US.
In mid-June, while announcing receipt of USFDA approval for the generic version Dr.Reddy’s had said it would be introducing the product in the US with an approved risk evaluation and mitigation strategy programme.
The Indivior statement said Dr.Reddy’s had sold a quantity of its generic buprenorphine/naloxone sublingual film into the U.S. market prior to the granting of the TRO on June 15. “The company does not know the exact quantity of product sold by DRL prior to the issuance of the TRO, but based on the recent abrupt loss of market share for its Suboxone film anticipates the FY 2018 net revenue impact to be at least $ 25 million,” the British drugmaker said.
The Court also ordered the parties to submit a final proposed injunction order on July 16. It directed Indivior to post a bond to provide security to DRL should the court conclude at the end of patent litigation that the ‘305 patent is invalid and/or not infringed. The bond amount will be determined by the court at a later date.
The court’s decision does not prevent patients or payers from accessing existing generic sublingual buprenorphine/naloxone medications as all currently available treatments are unaffected by the ruling. The U.S. market for medication-assisted treatment is already highly competitive with multiple therapies available, over half of which are generic medicines, Indivior said.
