Access to the PPM Journal and newsletters is FREE for clinicians.

Sandoz Announces Generic Version of Suboxone

The buprenorphine and naloxone sublingual film is now available in the US

A PPM Brief

Sandoz (Princeton, NJ) has announced1 that a generic version of the sublingual film Suboxone (buprenorphine and naloxone), based on the brand product by Indivior (UK), is now available in the US: 2mg/0.5mg, 4mg/1mg, 8mg/2mg and 12mg/3mg. The medication is indicated for the treatment of opioid dependence and should be used as part of a comprehensive treatment plan. The release of this generic Suboxone by Sandoz becomes the fourth of its kind currently on the market.

The company has stated that it is collaborating with partners and healthcare professionals toward addressing substance and opioid abuse. In an adjunct effort, the company is developing and commercializing FDA-approved prescription digital therapeutics for the outpatient treatment of substance abuse and opioid use disorders.

"We are excited to have the opportunity to further increase access to this critical medicine in the US market,” said Carol Lynch, president of Sandoz, in a press release. “Sandoz is well-positioned to deliver another important treatment alternative for patients suffering from addiction.”

A Brief History of Suboxone

In June 2018, FDA approved the very first generic versions of Suboxone sublingual films (from both Mylan Technologies and Dr. Reddy's Laboratories) as part of an ongoing effort to promote drug competition, lower prices, and expand access to medication-assisted treatment. In June 2017, FDA announced that it was seeking to spur innovation by allowing for accelerated approvals of generic drugs without competitors as part of its Drug Competition Action Plan.

However, shortly thereafter, controversy surrounding the approval led to manufacturer Indivior obtaining a temporary restraining order blocking Dr. Reddy’s Laboratories from launching a generic version of their product. “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,” said Shaun Thaxter, CEO of Indivior, in a statement from the company. In response, Dr. Reddy Laboratories stated: “the court order does not include a prohibition on commercial manufacturing of the product.”

In December 2018, the US Court of Appeals for the Federal Circuit concluded that Dr. Reddy’s had not infringed on Indivior’s patent, allowing Dr. Reddy’s generic to reenter the market. In response, Indivior has since released its own generic of Suboxone in January 2019, partnering with Alvogen Pine Brook (New Jersey).

Last updated on: April 1, 2019
Continue Reading:
Treating the Opioid-addicted Chronic Pain Patient: The Role of Suboxone
close X