US court clears way for Dr Reddy’s to sell generic Suboxone

By: | Published: February 13, 2019 5:51 AM

Dr Reddy’s had booked sales of around $10-$15 million, days after its launch before it was stayed by the US court. Suboxone had sales of around $786 billion in the US for the first nine months of 2018. The drug accounts for about 80% of Indivior’s sales.

Dr Reddy’s had booked sales of around - million, days after its launch before it was stayed by the US court.

The US Court of Appeals for the Federal Circuit (CAFC) has cleared the path for Dr Reddy’s Laboratories for selling generic version of Suboxone film in the market after a court mandate is expected to be issued on February 19. With this, Dr Reddy’s is allowed to sell generic version of the UK-based Indivior opioid treatment Suboxone sublingual film next week.

The US appeals court rejected Indivior claim to appeal in the Supreme Court and permitted Dr Reddy’s to go ahead with marketing of the drug. However, the launch will be ‘at risk’ till the preliminary injunction is lifted. Along with Dr Reddy’s, two other companies Mylan and Alvogen Pine Brook, will also be launching the generic version of Suboxone.

The court decision vacates the district court’s preliminary injunction that had prohibited Dr Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. In June, the US Food and Drug Administration (USFDA) approved Dr Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialisation activities halted as a result of a court-imposed temporary restraining order (TRO) against Dr Reddy’s. The TRO did not include a prohibition on commercial manufacturing of the product.

Suboxone film was first approved by the US Food and Drug Administration (USFDA) in 2010, and is considered faster and easier to take for patients than tablets. The tablet form of Suboxone was first approved by regulators in 2002 and is already available as a generic and is used in helping patients kick powerful opioid painkillers.

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According to few analysts, Dr Reddy’s had booked sales of around $10-$15 million, days after its launch before it was stayed by the court. Suboxone had sales of around $786 billion in the US for the first nine months of 2018. The drug accounts for about 80% of Indivior’s sales.

Meanwhile, Indivior also plans to launch an authorised generic of Suboxone film to capture some share of the generic segment and to generate a modest amount of net revenues. It is learnt that it could launch a cheaper version of its blockbuster, Suboxone, as soon as rivals release generic versions of the drug.

Analysts had estimated a sales opportunity of $100 million for Dr Reddy’s assuming limited competition. Brokerage firm Investec said the recent spate of approvals for other companies to market the drug could shorten the period of high profitability for Dr Reddy’s, hurting overall economics. It said the overall opportunity would be reduced significantly by second quarter of FY20, with four to five players coming into the market.

Meanwhile, in an another battle, the US Patent and Trademark Office (USPTO) has declined to move forward with Dr Reddy’s challenge to Celgene’s Revlimid. Dr Reddy’s is hoping to make a generic version of Revlimid. Revlimid is a cancer drug and is Celgene’s biggest revenue maker in 2018 and generated $9.69 billion in worldwide sales, nearly $6.47 billion of which came from the US.
Both Mylan and Dr Reddy’s were vying to make copycats of Revlimid. Revlimid’s patents extend until 2024 in the US and 2027 in Europe.

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