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22 November 2018Americas

Indivior loses battle over Suboxone generic

The US Court of Appeals for the Federal Circuit vacated a preliminary injunction against India-based Dr Reddy’s earlier this week, in a blow for addiction treatment drug producer  Indivior.

On Tuesday, November 20, the Federal Circuit opened the door for Dr Reddy’s to produce a generic version of Suboxone (buprenorphine and naloxone) Film, an opioid use disorder therapy.

In June this year, Indivior obtained a temporary restraining order from the US District Court for the District of New Jersey against the Indian generic maker. The district court granted Indivior a preliminary injunction in July.

“Because the district court’s conclusion that Indivior was likely to succeed on the merits was based on an erroneous interpretation of claim scope, we vacate the preliminary injunction,” said the Federal Circuit earlier this week.

In a press release published soon after the judgment, Indivior said that it will file a petition for both panel rehearing and rehearing en banc of the ruling.

Indivior also admitted that if a generic version of Suboxone Film were to enter the market in 2018, the result would “most likely be a rapid and material loss of market share” for Indivior’s own product.

“Industry analogues suggest that a launch in the US of a generic product that can be directly substituted by a pharmacist for the branded product without consultation with the patient would result in the branded incumbent losing up to 80% of its market share within a matter of months,” it added.

Any generic launch from Dr Reddy’s would be on an at-risk basis, subject to the outcome of the appeal of the non-infringement judgments related to US patent numbers 8,603,514 and 8,017,150, and ongoing litigation in New Jersey asserting recently-granted Orange Book-listed patents.

Shaun Thaxter, CEO of Indivior, said: “We are surprised and disappointed that the court has vacated the preliminary injunction.”

He added: “While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces challenges in the intervening period resulting from a potential material and rapid loss of market share to generic buprenorphine/naloxone sublingual film competition, including reduced earnings and cash flow.”

Dr Reddy’s said that it would resume its launch activities as soon as permitted.

In June, the US Food and Drug Administration approved Dr Reddy’s generic product in four strengths for sale in the US market.

A Dr Reddy’s spokesperson said: “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.”

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More on this story

Americas
5 February 2019   Rivals of British pharmaceutical company Indivior will soon be able to sell generic versions of opioid addiction treatment Suboxone film following a ruling of the US Court of Appeals for the Federal Circuit.
Americas
22 February 2019   Indivior has launched a generic version of its opioid addiction drug Suboxone (buprenorphine and naloxone) Film, one day after the US Supreme Court denied its request to put a lower court’s ruling on hold.
Big Pharma
30 November 2021   The US Court of Appeals for the Federal Circuit has affirmed a US Patent Trial and Appeal Board decision that held that claims of a patent for dissolvable films containing therapeutic agents were anticipated.

More on this story

Americas
5 February 2019   Rivals of British pharmaceutical company Indivior will soon be able to sell generic versions of opioid addiction treatment Suboxone film following a ruling of the US Court of Appeals for the Federal Circuit.
Americas
22 February 2019   Indivior has launched a generic version of its opioid addiction drug Suboxone (buprenorphine and naloxone) Film, one day after the US Supreme Court denied its request to put a lower court’s ruling on hold.
Big Pharma
30 November 2021   The US Court of Appeals for the Federal Circuit has affirmed a US Patent Trial and Appeal Board decision that held that claims of a patent for dissolvable films containing therapeutic agents were anticipated.