Avanir Pharmaceuticals, Inc. (
recently entered into a settlement agreement with
generic arm Sandoz, Inc. to resolve their patent litigation
regarding Neudexta. Sandoz had filed an abbreviated new drug
application (ANDA) to get its generic version of Avanir's
However, with the litigation being settled, Sandoz can now
sell its generic version of Nuedexta on Jul 30, 2026 or before
under certain circumstances. Avanir and Sandoz have also filed
for the dismissal of the patent litigation.
Meanwhile, four other companies have also filed ANDAs for
their generic versions of Nuedexta. These companies include Par
Pharmaceutical Companies, Inc.,
Actavis, Inc. (
Wockhardt, Ltd. and
Impax Laboratories, Inc. (
). Litigation against these ANDA filers is in progress.
We note that Nuedexta was launched in the U.S. in Jan 2011 for
the treatment of pseudobulbar affect (PBA). Net Nuedexta revenues
grew 15.2% sequentially to $19 million in the third quarter of
In Jun 2013, Avanir received approval for Nuedexta in the EU
for the treatment of patients suffering from PBA. The marketing
application was based on comprehensive data from phase III
studies of Nuedexta in patients with PBA, plus data from
longer-term safety studies.
Avanir expects to report top-line data from the PRIME study in
the fourth quarter of calendar 2013. This study is being
conducted to evaluate the efficacy of Nuedexta for the treatment
of central neuropathic pain in multiple sclerosis.
This drug is being studied for two additional indications,
namely, agitation in Alzheimer's disease (phase II), and
levodopa-induced-dyskinesia in Parkinson's disease (phase
Avanir currently carries a Zacks Rank #3 (Hold). Currently,
Actavis looks better positioned with a Zacks Rank #2 (Buy).
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