BRIEF—Indivior gets preliminary injunction against Dr Reddy's

UK-headquartered Indivior today announced that the US District Court for the District of New Jersey has granted a preliminary injunction (PI) against Indian generic drugmaker Dr Reddy's Laboratories.

The restrictions of the previously entered temporary restraining order (TRO) remain in place, and Dr Reddy’s is unable to sell, offer to sell, or import its generic buprenorphine/naloxone sublingual film product, marketed by Indivior as Suboxone Film, pending the outcome of recently filed litigation against Dr Reddy’s related to US Patent No. 9,931,305 (the '305 patent), or a decision of the US Court of Appeals for the Federal Circuit dissolving the injunction.

For its part, Dr Reddy’s Laboratories along with its subsidiaries on Saturday announced its intent to appeal the decision made by the US District Court. The company disagrees with the court’s decision, and will vigorously appeal it.

The Court has also ordered the parties to submit a final proposed injunction order on Monday, July 16.

Additionally, the US District Court for the District of New Jersey has ordered Indivior to post a bond to provide security to Dr Reddy’s 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.

As noted in the press releases Indivior published on June 15 and July 11, Dr Reddy’s sold a quantity of its generic buprenorphine/naloxone sublingual film into the US market prior to the granting of a temporary restraining order (TRO) on June 15.

Indivior does not know the exact quantity of product sold by Dr Reddy’s 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.

Reflecting this and other US market developments, Indivior noted that its FY 2018 financial guidance is no longer valid and that it cannot reliably provide updated FY 2018 net revenue and adjusted net income guidance until the impact of the Indian firm’s launch is better understood.

The company expects that this will be no later than its third quarter results announcement, currently scheduled for November 1.