Indivior pledges to appeal generic Suboxone decision
UK-based Indivior has pledged to appeal a US court decision that found a drug developed by generics maker Alvogen doesn’t infringe three of Indivior’s patents.
Alvogen had filed an Abbreviated New Drug Application (ANDA) of Indivior’s opioid addiction treatment, Suboxone (buprenorphine and naloxone) Film.
On Thursday, March 22, the US District Court for the District of Delaware found that Alvogen didn’t infringe the asserted claims of US patent numbers 8,017,150; 8,603,514; or 8,900,497, all of which cover the process for drying the sublingual film.
In a statement, Indivior, which specialises in addiction treatment drugs, said it believes has grounds to appeal against the ruling.
The UK company added that unless the decision is overturned, it may have “increased difficulty successfully defending” its IP against future ANDA filers.
As of March 22, the Food and Drug Administration had not indicated that it had granted tentative or final marketing authorisation to Alvogen’s generic Suboxone alternative.
Indivior’s fight is not over—the UK company has asserted two new Orange Book-listed patents against Alvogen and certain other ANDA filers claiming infringement.
Shaun Thaxter, CEO of Indivior, said: “We will appeal this ruling and continue to vigorously defend our IP, including asserting the two new Orange Book-listed patents that have been granted for Suboxone. We remain confident in Indivior’s long-term outlook and vision.”
In September last year, Indivior settled a Suboxone dispute with Mylan.
In the same month, Indivior suffered a loss at the Delaware court, after the court issued a finding that Dr. Reddy’s, Watson’s (Actavis) and Par’s proposed generic products do not infringe the ‘150, ‘514 and ‘497.
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