Jazz Pharmaceuticals Announces Paragraph IV ANDA Filing for Xyrem
PALO ALTO, Calif., Oct 05, 2010 /PRNewswire via COMTEX/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the website of the US Food and Drug Administration indicates that an Abbreviated New Drug Application (ANDA) for a generic version of Xyrem® (sodium oxybate oral solution) 500 mg/ml was submitted on July 8, 2010. Jazz Pharmaceuticals has not received a Paragraph IV certification with respect to this filing.
Jazz Pharmaceuticals intends to vigorously enforce its intellectual property rights. Xyrem is protected by seven patents covering its formulation and the company's distribution system for the product, including five patents listed in the FDA's Approved Drug Products List (the Orange Book).
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see http://www.jazzpharmaceuticals.com/.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, Jazz Pharmaceuticals' intent to vigorously enforce its intellectual property rights. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of the company to protect its intellectual property and defend its patents, the possible introduction of generic products, the dependence of the company on sales of Xyrem, and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere inJazz Pharmaceuticals'Securities and Exchange Commission filings and reports, including in itsQuarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August 11, 2010. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
SOURCE Jazz Pharmaceuticals, Inc.