Dr Reddy’s can’t sell generic opioid treatment, judge says

Washington • Indivior plc persuaded a federal judge to block sales of Dr Reddy’s Laboratories Ltd’s copies of opioid treatment Suboxone film, while a patent-infringement lawsuit is pending.

Dr Reddy’s had received approval in June from the US Food and Drug Administration (FDA) to sell a generic version of Indivior’s market-leading treatment for opioid dependence, but was temporarily blocked from selling the medicine while the judge took a closer look at the legal dispute.

A Dr Reddy’s representative said the company “strongly disagrees” with the findings of a federal judge in Newark, New Jersey, and plans to appeal. Officials at Indivior didn’t immediately comment on the ruling.

At this stage of the case, Indivior is likely to win its arguments on validity and infringement, and there are other alternatives to the drug that can be sold while the patent dispute continues, US District Judge Kevin McNulty said in his ruling last Friday.

“Entry of a generic would cause Indivior to lose market share” that couldn’t be repaired, the judge said.

Indivior had lost other cases against generic drug companies, including Dr Reddy’s, on other patents for Suboxone film. Dr Reddy’s had argued that this patent, issued in April, was little different than an earlier one for Suboxone. The judge disagreed, saying that while the two “largely overlap”, there are enough differences to set them apart.

Opioid Abuse

Opioid abuse affects about two million adults in the US, and the National Institute on Drug Abuse estimates 115 people die every day because of an opioid overdose. Suboxone’s active ingredients of buprenorphine and naloxone can suppress withdrawal symptoms and decrease cravings.

The active ingredient is available as a generic drug in tablets and injected treatments, but the film placed under the tongue is considered easiest to use. The judge said although his ruling prevents the entry of Dr Reddy’s generic film into the market, the public interest is served because other non-film generics remain available.

The market for drugs that treat opioid abuse totalled almost US$2.8 billion (RM11.34 billion) during the past 12 months, according to Symphony Health data reported by Bloomberg Intelligence. Overall sales for the class have flattened, but are expected to accelerate due to an increase in opioid-related deaths.

Suboxone is the best-selling opioid treatment, and competes with Alkermes plc’s Vivitrol and Orexo AB’s Zubsolv, Symphony data show. The analysis excludes methadone, a drug that also treats opioid addiction but is subject to stricter Centres for Disease Control guidelines.

Under Tongue

Suboxone film, absorbed by being placed under the tongue or inside the cheek, treats addiction to opioids, including heroin and prescription painkillers. The drug combines buprenorphine, which tricks the brain into thinking it’s still getting the drug, with naloxone, a medicine used to reverse the effects of an overdose.

In its annual report, Indivior, based in Slough, England, said it was “at risk of potential significant loss of market share” in the US if Dr Reddy’s received FDA approval for its generic version and decided to enter the market.

Indivior has been preparing to address the risk of generic competition to its flagship drug. That includes focusing on the launch of Sublocade, which the FDA approved as a once-monthly, extended-release buprenorphine injection to treat opioid-use disorder. Sublocade was made available to US patients on March 1. Indivior, in its annual report, said the drug was among its “key pipeline assets” in the US in 2018.

Indeed, Indivior spent US$180,000 on lobbying during the first quarter of 2018, partly in support of a bill — one of dozens related to opioids the US House of Representatives passed during recent weeks — that eases restrictions on some controlled sub- stances used in injectable anti-opioid treatments. The change would make it easier for doctors to buy Sublocade.

Still, the company said on May 1 in its quarterly report that the combination of a successful patent challenge by a generics company, a commercial launch of generic Suboxone film and an unsuccessful launch of Sublocade “would result in a significant change to the structure of the business”. — Bloomberg