Federal Appeals Court Expedites Dr. Reddy’s Appeal Over Anti-Opioid Dependence DrugBy
A federal appeals court has granted in part a motion to expedite Dr. Reddy’s Laboratories’ appeal of a preliminary injunction (PI) that was granted to Indivior, a Slough, UK-headquartered pharmaceutical company, over Dr. Reddy’s generic of Indivior’s drug for treating opioid dependence. The PI, granted by a federal district court last month (July 2018), prohibits Dr. Reddy’s from selling or commercializing its generic of Indivior’s Suboxone Film (buprenorphine/naloxone) sublingual film product.
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. A federal district court had granted Indivior a temporary restraining order in June 2018 that compelled Dr. Reddy’s to immediately cease launch activities related to its generic Suboxone Film. 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. Indivor then was granted a preliminary injunction against Dr. Reddy’s in July 2018 against further sales and commercialization of Dr. Reddy’s Suboxone Film generic.
Dr. Reddy’s appealed the ruling granting the PI and filed emergency motions seeking to expedite the appeal of the PI and to stay (i.e., suspend) the PI pending a ruling on appeal. The US Court of Appeals for the Federal Circuit has not yet ruled on Dr. Reddy’s motion to stay the PI. Under the expedited schedule, oral arguments will be held during the first week of October 2018. Indivior says it will continue to defend its patent rights to Suboxone Film, including opposing Dr. Reddy’s PI appeal.
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.