Impax Confirms Patent Challenge Relating to Renvela(R) 800 mg Tablets

April 6, 2009

HAYWARD, Calif., Apr 06, 2009 (BUSINESS WIRE) -- Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of the patents listed by Genzyme Corporation in connection with its Renvela(R) (sevelamer carbonate) 800 mg tablets.

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Renvela(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 owner of its paragraph IV certification.

On April 3, 2009, Genzyme filed suit for patent infringement against Impax in the United States District Court for the District of Maryland. 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.

Renvela(R) is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. According to Wolters Kluwer Health, U.S. sales of Renvela(R) 800 mg tablets were approximately $40 million for the twelve months ended February 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; ability to timely file periodic reports required by the Exchange Act; ability to maintain an effective system of internal control over financial reporting; ability to sustain profitability and positive cash flows; ability to maintain sufficient capital to fund operations; any delays or unanticipated expenses in connection with the construction of our Taiwan facility; ability to successfully develop and commercialize pharmaceutical products; the uncertainty of patent litigation; consumer acceptance and demand for new pharmaceutical products; the impact of competitive products and pricing; the difficulty of predicting Food and Drug Administration ("FDA") filings and approvals; inexperience in conducting clinical trials and submitting new drug applications; reliance on key alliance agreements; the availability of raw materials; the regulatory environment; exposure to product liability claims; fluctuations in operating results and other risks detailed from time to time in our 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