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UK drug firm Indivior to appeal US ruling on Dr Reddy's generic drug
[BENGALURU] Indivior said on Friday it would appeal against a US court ruling that generic drug maker Dr Reddy's had not infringed its patents, potentially opening the way to a rival to the firm's Suboxone Film opiod addiction treatment.
Indivior has said it would not be able to rely on patents to prevent Dr Reddy's from making and marketing a generic alternative to Suboxone Film in the United States, unless the court's ruling was reversed on appeal.
The firm said the average market share of Suboxone Film in the United States was 61 per cent in 2016, and accounted for 80 per cent of Indivior's total revenues last year.
Shares in Indivior were forecast to open down 10-15 per cent at the market opening, after the ruling by the US Delaware District Court.
Indivior said in a statement it could not quantify the precise financial impact of generic alternatives to Suboxone Film on revenues but said it "could potentially result in a rapid and material loss of market share for Suboxone Film in the US".
Indivior said if pharmacies could substitute Suboxone Film with a generic rival without direct consultation with the patient it could lead to the British firm's treatment losing up to 80 per cent of its market share "within a matter of months".
Indivior said that as of Aug 29 the US Food and Drug Administration (FDA) had not announced it had granted tentative or final marketing authorisation to any generic Suboxone Film alternative.
If the FDA grants approval to Dr Reddy's, the British firm said its rival would be able to market a generic alternative to Suboxone Film in the United States.
Indivior said in June that it had won a US patent battle against Actavis and Par Pharmaceutical over Suboxone Film.