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Impax Laboratories Confirms Patent Challenge Relating to TRICOR(R) 48mg and 145mg Tablets

Fri. October 30, 2009; Posted: 10:45 AM
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HAYWARD, Calif., Oct 30, 2009 (BUSINESS WIRE) -- IPXL | Quote | Chart | News | PowerRating -- Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR(R) (fenofibrate) tablets, 48 mg and 145 mg.

Impax filed its Abbreviated New Drug Application ("ANDA") containing a Paragraph IV certification for a generic version of TRICOR(R) with the U.S. Food & Drug Administration ("FDA"). Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its Paragraph IV certification.

On October 29, 2009, Abbott Laboratories and Laboratoires Fournier S.A. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.

TRICOR(R) is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dislipidemia (Fredrickson Type IIa and IIb). TRICOR(R) is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Type IV and V hyperlipidemia). According to Wolters Kluwer Health, aggregate U.S. sales of TRICOR(R) were approximately $1.5 billion for the twelve-month period ending August 2009.

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, Inc.

Impax Laboratories, Inc. 
Mark Donohue 
Sr. Director Investor Relations 
215-933-3526 
www.impaxlabs.com
For full details for IPXL click here.

    


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