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Avanir Pharmaceuticals,
Inc.
AVNR today announced that it has entered into a settlement
agreement with Sandoz, Inc. to resolve pending patent litigation in response
to Sandoz's abbreviated new drug application (ANDA) seeking approval to market
generic versions of Avanir's NUEDEXTA® (dextromethorphan
hydrobromide/quinidine sulfate) capsules.
The settlement agreement grants Sandoz the right to begin selling a generic
version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances.
The parties have also agreed to file a stipulation and order of dismissal with
the United States District Court for the District of Delaware which will
conclude this litigation with respect to Sandoz. The settlement does not end
Avanir's ongoing litigation against the other four ANDA filers.
In compliance with U.S. law, the settlement agreement will be submitted to the
U.S. Federal Trade Commission and the Department of Justice where it is
subject to review.
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