ALISO VIEJO, Calif., July 1, 2011 /PRNewswire/ — Avanir
Pharmaceuticals, Inc. (NASDAQ:
AVNR) today announced that the U.S. Food and Drug
Administration (FDA) website indicates that an Abbreviated New Drug
Application (ANDA) for a generic version of NUEDEXTA®
(dextromethorphan hydrobromide and quinidine sulfate) capsules was
submitted on March 7, 2011. The company received Paragraph IV
certification notices on June 30, 2011.
Avanir intends to vigorously enforce its intellectual property
rights relating to NUEDEXTA, which is protected by several patents
covering the method of use of the product and its formulation. All
of the currently issued patents are listed in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations, commonly
known as the Orange Book. Under the FDA’s rules and regulations, if
Avanir initiates a
patent infringement suit to defend the patents identified in
any Paragraph IV notice it receives within 45 days after its
receipt of such notice, the FDA is prevented from approving the
ANDA until the earlier of: (1) 30 months; (2) the expiration of the
patents at issue; or (3) a decision in the infringement case that
all of such patents are not infringed or invalid.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company
focused on bringing innovative medicines to patients with central
nervous system disorders of high unmet medical need. As part of our
commitment, we have extensively invested in our pipeline and are
dedicated to advancing medicines that can substantially improve the
lives of patients and their loved ones. For more information about
Avanir, please visit www.avanir.com.