Indivior has sought an injunction against Dr. Reddy’s after the Indian drugmaker – in collaboration with Mylan – received US Food and Drug Administration (FDA) approval for a generic alternative to Indivior’s Suboxone sublingual film.
The June 14 approval marked the first entry of a generic Suboxone product to enter the US market. The film is comprised of buprenorphine to help supress opioid withdrawal symptoms, and naloxone, which reverses and blocks narcotic effects.
But on June 15, Indivior expressed concerns that ongoing patent litigation between the parties – regarding US Patent No. 8,603,514 – had not been resolved before launch.
“We are surprised by Dr. Reddy’s decision to launch ‘at risk’ given the ongoing litigation and associated significant risk to them of substantial economic damages if, as we believe, we eventually prevail in protecting the Suboxone Film patent estate,” said Indivior’s CEO Shaun Thaxter in a statement.
According to Indivior, a generic version of Suboxone Film in the US could result in a “rapid and material loss of market share” within months of launching a generic film alternative.
“In the meantime, we will continue to pursue all legal avenues, including an immediate injunction until the legal status of our intellectual property is confirmed by the Courts,” said Thaxter
Dr. Reddy’s responds
On June 16, Dr. Reddy’s defended its right to launch the sublingual product in the US.
The Indian drugmaker clarified the proceeding relates to US Patent No. 9,931,305 only, and does not prohibit commercial manufacturing of the product, adding, “the plaintiffs will be required to post a bond or other security totalling $18m [€15.5m] to satisfy any losses or damages incurred by Dr. Reddy’s during the period of the temporary restraining order.
“The court has scheduled an expedited hearing of the preliminary injunction for Thursday, June 28, and a ruling is expected soon thereafter.”