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Omeprazole Delayed Release Capsules Launched

HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 8, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced today that its Omeprazole Delayed Release Capsules 20mg have been commercially launched by Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA). Omeprazole Delayed Release Capsules are a generic version of Prilosec(R) marketed by AstraZeneca for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux disease). According to NDC Health, U.S. sales of Prilosec 20mg and its generic equivalents were $1.2 billion for the twelve months ending June 30, 2004.

As provided for in the Strategic Alliance Agreement between IMPAX and Teva signed in June 2001, as amended, the parties have agreed to certain risk-sharing arrangements relating to an Omeprazole launch. AstraZeneca previously commenced litigation against IMPAX and other generic manufacturers arising from the marketing of Omeprazole Delayed Release Capsules, 10mg, and 20mg and 40mg. This litigation is currently pending.

"The launch of Omeprazole Delayed Release Capsules 20mg is another milestone in the growth of our company," said Barry R. Edwards, CEO of IMPAX. "While there are already several competitors in this market, we believe in Teva's ability to effectively gain distribution, over time, in this large generic market."

IMPAX currently has 14 applications pending at the FDA, including five tentatively approved, which address approximately $4.9 billion in U.S. product sales for the twelve months ended June 30, 2004, based on NDCHealth data. Ten of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

Source: IMPAX Laboratories, Inc.

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