US court rules in favour of Dr Reddy's, allows sale of generic Suboxone

Dr Reddy's Laboratories Ltd Wednesday said a court in the US has given a ruling in favour of it in a patent infringement case filed by pharma giant Indivior on selling a generic version of Suboxone a sublingual film in the American market.

According to a press release issued by the city-based drug maker, the United States Court of Appeals for the Federal Circuit concluded that Indivior had not shown that it is likely to succeed on the merits of its infringement case.

It also said this decision vacates a District Court"s preliminary injunction that had prohibited Dr Reddy's from selling its generic version of Suboxone (buprenorphine and naloxone).

Buprenorphine and naloxone are used to treat adults with opioid dependence or addiction.

As a result of today's ruling, Dr Reddy's will resume its launch activities as soon as it is permitted, it said.

According to market reports, suboxone had sales of around $1.86 billion in the US for the 12 months ended April.

A company spokesperson said, "We are pleased with the decision of the appellate court in Dr Reddy's favour, vacating the preliminary injunction that had prevented Dr Reddy's from bringing this important drug to the public.

We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and in particular look forward to taking the lead in helping to fight Opioid Use Disorder."

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 against Dr Reddy's.

The TRO did not include a prohibition on the commercial manufacturing of the product.