The U.S. District Court for the District of New Jersey has restrained Dr. Reddy’s Laboratories from selling the generic version of British drugmaker Indivior’s Suboxone in the U.S., pending the outcome in a litigation over the patent of the opioid dependence treatment.
Announcing the preliminary injunction against the Hyderabad-based firm, Indivior said in a statement that following the injunction restrictions imposed by a prior temporary restraining order (TRO) remained in force.
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 … the 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.”
Responding to the development, DRL on Saturday said “the company disagrees with the court’s decision and will vigorously appeal it.”
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 U.S. with an approved risk evaluation and mitigation strategy programme.
The Indivior statement said DRL had sold a quantity of its generic buprenorphine/naloxone sublingual film in the U.S. prior to the granting of a 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 FY2018 net revenue impact to be at least $25 million,” the British firm 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 later.
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