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Orexo wins patent litigation in the US

Nikolaj Sørensen

The US District Court for the District of New Jersey ruled in favor of Orexo in its patent litigation against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc. (collectively “Sun”) regarding ZUBSOLV (buprenorphine and naloxone) sublingual tablets (CIII) in the US.

The district court found that Orexo’s patents are valid and infringed by Sun.

Yet another time we have received confirmation about the strength of our patents protecting the innovation and technology behind ZUBSOLV.”

“I am very pleased that me and my team in both the US and Sweden, yet another time have received confirmation about the strength of our patents protecting the innovation and technology behind ZUBSOLV. Since its launch in the US in 2013, ZUBSOLV has generated more than SEK 4.7 billion in net revenues and will continue to be an important cash generator. I want to thank all our shareholders and, most importantly, the employees for their continued support and commitment during the last three years. Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients,” says Nikolaj Sørensen, President and CEO of Orexo.

Read more: Nikolaj Sørensen – In a business state of mind

As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV tablets until September 2032, and Orexo’s patent protection remain unchanged.”

The district court’s decision concludes the litigation that was initiated in September 2020 as a response to Sun’s submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV. As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV tablets until September 2032, and Orexo’s patent protection remain unchanged.

ZUBSOLV is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

The win will enable Orexo to maintain ZUBSOLV net sales and profit contribution (SEK 573 million and SEK 299 million respectively the last twelve months), the company states.

Photo of  Nikolaj Sørensen: Orexo

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