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Orexo Settles Abstral® US Patent Litigation with Actavis

27-Oct-2015 | Source : Orexo | Visits : 6772
UPPSALA, Sweden – Orexo AB (publ) announced in a press release that it has entered into a settlement and license agreement with Actavis Laboratories FL, Inc. (“Actavis”) to settle the patent litigation regarding Abstral® in the US.
The agreement settles the patent infringement litigation commenced early this year by Orexo following Actavis’ filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market generic versions of Abstral® (fentanyl) sublingual tablets in the U.S. prior to the expiration of Orexo’s patents listed in FDA’s Orange Book for Abstral®.

The agreement allows Actavis to enter the market in June 2018, or earlier under certain conditions. Orexo’s patents listed in FDA’s Orange Book for Abstral® expire in September 2019.

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