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.

“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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.