Patent litigation over Dr. Reddy’s Suboxone generic continues

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Hailshadow)
(Image: Getty/Hailshadow)

Related tags: Opioid epidemic, Patent, Patent application, patent infringement, Generic drug, Generics

The US Court of Appeals for the Federal Circuit removed the injunction against Dr. Reddy’s, which prevented the company from selling its Suboxone generic.

Indivior, which holds the patent to combination buprenorphine and naloxone treatment, Suboxone, through a partnership with Aquestive, requested the previous and now overruled injunction.

The decision to lift the injunction will enable Dr. Reddy’s generic to re-enter the market.

After the court’s ruling​, Aquestive stated that while the company is disappointed in the decision to overturn the injunction, it will continue to work with Indivior to pursue infringement cases against Dr. Reddy’s.

Dr. Reddy’s filed a motion requesting that the Court of Appeals for the Federal Circuit (CAFC) to either issue the mandate, prohibiting the company from marketing the generic immediately, or stay the preliminary injunction until a mandate is issued.

By staying the preliminary injunction or issuing a mandate, the company will have a specific understanding of what it can and cannot do with its Suboxone generic.

Indivior stated that it will file a petition for a panel rehearing of the ruling that overturned the preliminary injunction.

Suboxone (buprenorphine/naloxone) can be prescribed for the treatment of opioid use disorder. Prior to the injunction, the US Food and Drug Administration approved Dr. Reddy’s generic version of Suboxone to advance the treatment of opioid use disorder, amid the ongoing opioid epidemic​.

Following the approval, Indivior expressed concerns​ that patent litigation between the two companies had yet to be resolved and noted that the selling of Dr. Reddy’s generic was on an ‘at risk’ basis. In its financial reporting​, Indivior noted that Dr. Reddy’s generic entry into the market had impacted the firm’s market share.

Timing for Dr. Reddy’s entrance back into the market is unknown, as the preliminary injunction remains in effect until the issuance of a mandate by the CAFC.

Related topics: Regulatory & Safety, Regulations

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