Healthcare Industry News: duloxetine
News Release - November 18, 2008
Impax Sued Based on Anda for Generic Cymbalta(R)
HAYWARD, Calif. November 18, 2008--(HSMN NewsFeed)--IMPAX Laboratories, Inc. today announced Eli Lilly and Company has filed suit alleging infringement U.S. Patent No. 5,023,269 (the "'269 patent") in the United States District Court for the Southern District of Indiana based on the Company's submission of Abbreviated New Drug Application ("ANDA") for duloxetine hydrochloride delayed-release capsules (20, 30, and 60 mg), generic of Cymbalta(R), to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid claim of the '269 patent. The Company is aware of at least three additional lawsuits containing similar patent infringement claims based on the filing of ANDAs containing a Paragraph IV certification to the '269 patent. The Company's ANDA was submitted August 4, 2008, and the Company believes all filers of ANDAs submitted on that date will be entitled to 180 days of exclusivity under the applicable regulations.Cymbalta(R) is a selective serotonin and norepinephrine reuptake inhibitor indicated for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. According to Wolters Kluwer Health, U.S. sales of Cymbalta(R) were approximately $2.3 billion in the 12 months ended September 30, 2008.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of and suspension of trading in IMPAX's stock, IMPAX's failure to file any periodic reports subsequent to its quarterly report on Form 10-Q for the quarter ended September 30, 2004, the SEC's revocation of the registration of IMPAX's common stock under section 12 of the Securities Exchange Act of 1934, the actual time that will be required to,file a registration statement on Form 10 with respect to such stock, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Source: IMPAX Laboratories
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