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Jazz Pharmaceuticals Announces Issuance of Key Patent for Once-A-Day LUVOX CR
Thursday, December 18, 2008
Palo Alto, CA -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,465,462 covering its Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsule product. The patent was assigned to Elan Pharma International Limited and is exclusively licensed to Jazz Pharmaceuticals in the United States through a product license agreement with Solvay Pharmaceuticals, Inc. The patent claims the formulation incorporating Elan's SODAS (Spheroidal Oral Drug Absorption System) technology, as well as a method of using the formulation for the treatment of obsessive compulsive disorder (OCD).
LUVOX CR was approved on February 28, 2008 by the U.S. Food and Drug Administration (FDA) for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults. The patent has been listed for LUVOX CR in the FDA Orange Book.
About the FDA Orange Book
The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, lists all drug products that have been approved by FDA for safety and effectiveness. The Orange Book also includes information on patents which claim an approved drug product or method of use of the drug product, to facilitate the legal requirement that generic drug applicants include an appropriate certification to each such patent as part of any Abbreviated New Drug Application (ANDA) for a generic version of a listed drug.
About Elan Drug Technologies
Elan's Drug Technologies group has developed LUVOX CR using one of its proprietary Oral Controlled Release Technologies, the SODAS (Spheroidal Oral Drug Absorption System) Technology. Elan Drug Technologies (EDT) is an established, profitable and growing specialty pharmaceutical business unit of Elan Corporation, plc. For nearly 40 years, EDT has been applying its skills and knowledge to enhance the performance of dozens of drugs that have been marketed worldwide. EDT is focused on using its extensive experience, proprietary drug delivery technologies and licensing capabilities to develop innovative products that deliver clinically meaningful benefits to patients. More information about EDT's broad range of technologies including their Oral Controlled Release and NanoCrystal Technology Platforms, and its range of services is available at http://www.elan.com/EDT.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. The Company has an unwavering commitment to improving care for patients with serious psychiatric and neurological conditions through innovative treatments and distinctive and valuable programs for patients and physicians. 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, statements related to LUVOX CR. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that our intellectual property rights may not ensure protection of our products and the risk that our products might infringe the intellectual property rights of others. These and other risk factors are discussed under "Risk Factors" in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on November 14, 2008. 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.
SODAS and NanoCrystal are registered trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc (NYSE: ELN).
LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.
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