The recently announced agreement resolves the patent litigation commenced in 2020 by Orexo following Sun’s filing of an Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of Zubsolv in the US prior to the expiration of Orexo’s patents listed in FDA’s Orange Book for Zubsolv.

Describe what this decision means for Orexo’s continued journey?

“Orexo had a strong position in the patent litigation after prevailing in the district court, however there are always risks of an unfavorable decision in the court of appeal. With the settlement we gained certainty in our ability to continue with our profitable US business with exclusivity until 2030. This also enables much more strategic maneuver room in our ambition to optimize the value from our US business, both in terms of our own pipeline of projects and in terms of potential partnerships in the US.”  

This also enables much more strategic maneuver room in our ambition to optimize the value from our US business.

How do you prepare for the launch of Sun’s generic drug in 2030?

“With a fixed date we have the opportunity to prepare for the potential launch of a generic competitor. The certainty in when this happens will of course improve our ability to prepare for the competition and also, ahead of the launch of a generic, to optimize our cost structure since the return on investment from commercial investments will decline as we approach the time of generic competition. It is still many years before this will happen and we have no firm plans on how to act at that time that we can and will communicate.”

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Orexo resolves US patent litigation with Sun

Orexo has entered into a settlement agreement with Sun Pharmaceuticals Industries to resolve the patent litigation regarding Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII), for the treatment of opioid use disorder in the US.

It would be interesting to get your insight and perspective on these kinds of patent litigation processes and generic challenges, especially in the US?

“Orexo has unfortunately had extensive experience in patent litigation, this is the second one for Zubsolv, but we have also been involved in processes in the US with our other out-licensed products Abstral and Edluar. The US legal system has created a strong incentive for the generic companies to challenge the inventor of new products and we know they start the process to develop a generic version of new products more or less in parallel with the first launch of the branded product, i.e. it is a question of when and not if you will face a generic challenge.”

The US legal system has created a strong incentive for the generic companies to challenge the inventor of new products and we know they start the process to develop a generic version of new products more or less in parallel with the first launch of the branded product.”

“For Orexo these experiences have made the risk of generic competition a central part of any development project and preparations for a future patent litigation start in parallel with starting a new development project. It is also a central topic in any partner discussion whether is being partners in-licensing an Orexo product or Orexo looking to license a new technology. We find the lack of strong patent protection to be one of the key reasons to turn down multiple opportunities.”