Indivior, Dr. Reddy’s in Dispute Over Anti-Opioid Dependence Drug

A federal US district court has granted Indivior, a Slough, UK-headquartered pharmaceutical company, a temporary restraining order (TRO) that compels Dr. Reddy’s Laboratories to immediately cease launch activities related to its generic version of Indivior’s Suboxone Film (buprenorphine and naloxone), a drug for treating opioid dependence.

The US Food and Drug Administration (FDA) approved the first two generic versions of Indivior’s Suboxone sublingual (under the tongue) film to Dr. Reddy’s and Mylan in June 2018. The Suboxone brand had US sales of approximately $1.86 billion for the 12 months ending in April 2018, according to information from IQVIA (formerly IMS Health) and as reported by Dr. Reddy’s Laboratories.

Dr. Reddy’s launched the product “at risk,” according to information from Indivior. An “at-risk” generic drug launch occurs when a company launches a generic drug into the market while patent litigation is still ongoing. Indivior and Mylan came to an agreement in September 2017 to resolve patent litigation related to Suboxone.

Following the launch of Dr. Reddy’s Suboxone generic in the US this month (June 2018), the US District Court for the District of New Jersey received and reviewed an emergency application from Indivior for a temporary restraining order and preliminary injunction against Dr. Reddy’s. Pending a hearing and decision on the injunction application from Indivior, the court issued a temporary restraining order against Dr. Reddy’s with respect to further sales and commercialization of Suboxone Sublingual Film within the US.

Indivior will be required to post a bond or other security totaling $18 million to satisfy any losses or damages incurred by Dr. Reddy’s during the period of the temporary restraining order, according to information from Dr. Reddy’s. The court has scheduled an expedited hearing of the preliminary injunction for Thursday, June 28, and a ruling is expected soon thereafter. The proceeding involves one patent.

“Dr. Reddy’s remains confident in its legal positions on this patent and believes it will prevail on the issues raised with respect to the application for injunction,” Dr. Reddy’s said in a June 16, 2018 company statement.

Indivior said it has developed detailed contingency plans to be brought into effect in the event of actual market entry by Dr. Reddy’s. These include the potential launch of an authorized generic as well as defined operational cost savings measures. The company said that an overriding principle of these plans is to continue to support and optimize the launch of Sublocade, the company’s monthly buprenorphine extended-release injection for moderate to severe opioid use disorder.

Source: FDA, Indivior (TRO win), Indivior (settlement with Mylan), Indivior (Dr. Reddy’s generic-drug approval), Dr. Reddy’s Laboratories (Suboxone approval), Dr. Reddy’s Laboratories (launch defense)

Leave a Reply

Your email address will not be published. Required fields are marked *