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16 September 2020AmericasSarah Morgan

Orexo sues Sun Pharma over opioid dependence generic

Swedish pharmaceutical company Orexo has taken India-based Sun Pharmaceutical to court in the US, over its plans to launch a generic version of Orexo’s opioid dependence treatment.

Filed late last week at the US District Court for the District of New Jersey, the suit accused Sun Pharma and its US subsidiary of infringing five patents covering Orexo’s Zubsolv (buprenorphine and naloxone) sublingual tablets.

The suit comes in response to Sun Pharma’s filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) which seeks approval to commercially market generic versions of Zubsolv.

The five patents have expiration dates ranging from December 2027 to September 2032.

“Since Orexo timely filed a lawsuit against Sun, [the] FDA is statutorily precluded from approving Sun's ANDA for 30 months, or until a district court decision finds the patents to be invalid or not infringed, whichever occurs first,” said Orexo in a press release.

In August, Sun Pharma sent a written notice of its ANDA plan to Orexo, asserting that the patents-in-suit wouldn't be infringed.

The notice also contained an “offer of confidential access”, which allows brands an opportunity to evaluate the ANDA before filing suit to determine which patents to assert.

However, Orexo said that the terms of the offer were unreasonable and so it attempted to negotiate access on more reasonable terms, but that Sun Pharma had not provided confidential information.

Orexo is seeking a judgement that Sun Pharma has infringed its patents and injunctive relief to stop Sun Pharma from launching a generic until after the expiration of the patents-in-suit.

Nikolaj Sørensen, Orexo's president and CEO, said: “Today Orexo is much more well prepared to defend the exclusivity of Zubsolv than when we started our previous patent litigation. We successfully defended the exclusivity for Zubsolv in the past and we are well prepared to do so again by enforcing our patent rights against Sun.”

In January last year, the US District Court for the District of Delaware ruled that Actavis’s generic Zubsolv products infringed US patent number 8,940,330, preventing Actavis from commercialising its generic in the US until after September 18, 2032.

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More on this story

Americas
26 August 2020   Intercept Pharmaceuticals is suing Canadian generics manufacturer Apotex over a proposed version of autoimmune drug Ocaliva.
Americas
23 September 2020   Canada-based Bausch Health has dropped its litigation against Indian generic maker Sun Pharma as part of a settlement agreement.
Big Pharma
24 August 2023   Indian drugmaker had challenged PTAB decision that patent for new version of ruxolitinib was invalid as obvious | Decision hands a victory to US rival.