Oct 19 2010
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the website of the U.S. Food and Drug Administration (FDA) indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Silenor® (doxepin) 3 mg and 6 mg was submitted on September 16, 2010. Somaxon has not received a Paragraph IV certification with respect to this ANDA filing.
Somaxon intends to vigorously enforce its intellectual property rights relating to Silenor. Silenor is protected by eight patents covering the method of use of the product and its formulation, all of which 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 Somaxon 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 30 months, the expiration of the patents at issue or a decision in the infringement case that all of such patents are not infringed or invalid.
SOURCE Somaxon Pharmaceuticals, Inc.
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