Indian pharmaceutical company Dr Reddy’s Laboratories has announced that the US District Court in New Jersey has issued a temporary restraining order against the launch of its generic Buprenorphine and Naloxone Sublingual Film in the US market.
The company received approval from the US Food and Drug Administration (FDA) a day before the order was issued. The new drug is a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film.
Buprenorphine and naloxone are indicated for the treatment of opioid dependence/addiction. Buprenorphine suppresses withdrawal symptoms due to discontinuation of opioid drugs intake, while naloxone stops the effects of opioids.
The court issued the immediate injunction following an emergency application from the plaintiffs regarding the violation of a patent.
It prohibits Dr Reddy’s Laboratories from selling or commercialising the drug in the US. However, the order does not encompass commercial manufacturing.
The injunction also requires the plaintiffs to post a bond or other security amounting to $18m to cover any losses incurred by Dr Reddy’s during this period.
During the FDA’s approval process, Dr Reddy’s developed markets CEO Alok Sonig said: “With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone® could not have come at a more critical time to help patients.
“We are excited to be launching this important product that will help enable patients to prevail over this insidious disease.”
According to IMS Health, the Suboxone brand registered US sales of nearly $1.86bn MAT in the last 12 months ending April this year.