Salvation for Avanir in Patent Exclusivity

Health and Healthcare

Published: April 30, 2014 3:52 pm

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) is seeing a late day surge on Wednesday after news broke that the company has prevailed in a patent fight covering NUEDEXTA. This drug remains the only FDA-approved product for the treatment of pseudobulbar affect.

A press release from Avanir showed that a U.S. District Court for the District of Delaware has ruled in favor of Avanir in its patent infringement lawsuit against Par Pharmaceuticals, Inc. and Impax Laboratories, Inc. (NASDAQ: IPXL) in conjunction with their Abbreviated New Drug Applications for generic versions of NUEDEXTA capsules for the treatment of pseudobulbar affect.

The company’s release said,

“Following a six day bench trial in the District of Delaware, Judge Leonard P. Stark issued a ruling upholding the validity of the patents covering NUEDEXTA (US Patent Nos. RE38,115, 7,659,282 (the “‘282 patent”) and 8,227,484 (the “‘484 patent”), and holding that the proposed ANDA formulations infringe the claims of the ‘282 patent and ‘484 patent.”

According to Avanir, this decision provides twelve-plus years of market exclusivity for NUEDEXTA – out to 2026.

The website PBAInfo.org shows that nearly two million Americans with certain neurologic conditions or brain injuries are estimated to suffer from these uncontrollable outbursts of crying or laughing.

Avanir Pharma shares were up 47% at $5.01 with about 15 minutes to go before the closing bell. The volume of 10.6 million shares was close to 5-times normal trading volume, and Avanir’s stock has traded in a range of $2.62 to $6.00 over the last 52-weeks. Even after the pop. its market cap is around $766 million.

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