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27 June 2022Big Pharma

Dr Reddy’s to receive $72m in Suboxone settlement

India-based Dr Reddy’s has ended its litigation with Indivior and Aquestive Therapeutics over a generic version of opioid addiction treatment Suboxone (buprenorphine and naloxone) sublingual film.

In an announcement shared Friday, June 26, with the National Stock Exchange of lndia, Dr Reddy’s said that it will receive payments totalling $72 million by March 31, 2024.

The settlement resolves all claims between the parties relating to Dr Reddy’s generic version, including Indivior's and Aquestive's patent infringement allegations and Dr Reddy’s antitrust counterclaims.

The long-running dispute began after Dr Reddy’s filed an Abbreviated New Drug Application to market generic versions of Suboxone. Indivior markets and holds the New Drug Application for Suboxone.

Indivior secured a temporary restraining order against Dr Reddy’s in June 2018, after the US Food and Drug Administration approved Dr Reddy’s generic in four strengths.

In November that year, the US Court of Appeals for the Federal Circuit vacated the injunction which had stopped the India-based company from marketing its Suboxone generic in the US.

After a failed attempt to have the Federal Circuit stay its motion, Indivior filed a petition to stay the mandate with the US Supreme Court. However, the US’s highest court denied Indivior’s motion to stay issuance of the Federal Circuit’s mandate. One day later, Indivior launched its own authorised generic of Suboxone.

In the New Jersey litigation, Dr Reddy’s was given the green light to move forward with its antitrust counterclaims against Indivior in August 2020.

More recently, in November last year, the Federal Circuit affirmed a US Patent Trial and Appeal Board (PTAB) decision that held that claims of an Indivior patent for dissolvable films containing therapeutic agents were anticipated. Dr Reddy’s had instituted the inter partes review of the patent.

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More on this story

Americas
29 April 2021   Amarin delayed the market entry of generic versions of the cardiovascular drug Vascepa by using supply agreements to halt competitors from accessing the drug’s active pharmaceutical ingredient, according to a new antitrust lawsuit.
Big Pharma
11 February 2021   Celgene has filed a lawsuit against Indian drugs manufacturer Dr Reddy’s Laboratories to halt its plan to produce and market generic versions of Pomalyst—Celgene’s multiple myeloma treatment.