Indivior Warns US Court Ruling Opens Way for Generic Competition to Its Opiate Addiction Product

UK drugmaker Indivior (INDV.L) said on Friday that a US court ruling, which it intends to appeal, has opened the way for competitors to make generic copies of its Suboxone Film product for opiate addiction, which had a 61% market share in the US last year.

Shares of Slough, England-based Indivior plunged almost 40% after it said the US District Court for the District of Delaware that Dr. Reddy’s (RDY) does not infringe Indivior’s patents relating to Suboxone. Unless the ruling is reversed on appeal, Indivior believes it won’t be able to rely on its patents to prevent Dr. Reddy’s from manufacturing and marketing a generic film alternative in the US, potentially leading to a “a significante adverse impact” on its finances, it said.

“The company intends to continue vigorously defending its intellectual property and believes that it has grounds to appeal the ruling by the District Court of Delaware,” it said. The launch of a generic alternative “could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch.”

Based on industry research, the launch of a generic alternative, which could be directly substituted for a branded product, typically results in the branded incumbent losing up to 80% of its market share within a matter of months, Indivior said.

“A material loss in market share in the US would have a significant adverse impact on the company’s revenues, profitability and cash flows,” it said, without giving a more exact estimate. Sales of Suboxone Film in the US made up about 80% of Indivior’s revenue in 2016.

Indivior’s net revenue last year was $1.06 billion compared with $1.01 billion in 2015, according to the company’s website.

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