IVAX to Begin Marketing Gabapentin Capsules in March, Tablets in April, Prior to End of Alpharma's Exclusivity Periods

Business Wire, Feb 11, 2005

MIAMI -- IVAX Corporation Announces Settlement of Litigation Against FDA and Alpharma

IVAX Corporation (AMEX:IVX) (LSE:IVX.L) today announced that it has entered into a settlement of its litigation with the United States Food and Drug Administration and Alpharma Inc. regarding gabapentin, the generic equivalent of Neurontin(R). Pursuant to the settlement, Alpharma has waived its FDA awarded 180-day marketing exclusivity in favor of IVAX, effective on March 23, 2005 for gabapentin capsules, and April 29, 2005 for gabapentin tablets. As a result, IVAX will be able to market AB rated generic gabapentin capsules and tablets prior to the expiration of Alpharma's 180-day marketing exclusivity periods.

The litigation involved an appeal filed by IVAX in the United States Court of Appeals for the District of Columbia seeking to reverse a District Court decision upholding the FDA's award of marketing exclusivity to Alpharma for gabapentin capsules and tablets. Neurontin(R) is used to treat epileptic seizures and is marketed by Warner-Lambert, a unit of Pfizer Inc. IVAX is presently litigating whether its gabapentin products infringe a patent held by Pfizer. A trial in the U.S. District Court of New Jersey has not yet been scheduled.

IVAX previously announced that its ANDAs for gabapentin capsules in 100mg, 300mg, and 400mg dosage strengths, and tablets in 600mg and 800mg dosage strengths received tentative approval from the FDA. Upon final approval, these products will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. IVAX currently markets gabapentin tablets in 100mg, 300mg and 400mg dosage strengths, for which IVAX received 180-day marketing exclusivity.

IVAX continues its aggressive program to increase the number of products in its generic portfolio.

IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally. Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risks that launch of gabapentin capsules in 100mg, 300mg and 400mg dosage strengths, and tablets in 600mg and 800mg dosage strengths may be delayed or may not occur, and if launched, the products will not be successfully commercialized; that final approval of IVAX' ANDA for the 100mg, 300mg and 400mg capsules and/or 600mg and 800mg tablets may be delayed or not received at all; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; the difficulty in predicting the timing and outcome of legal proceedings, including the outcome of Pfizer's patent infringement claim against IVAX and others with respect to gabapentin; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; the impact of FDA's or other administrative or judicial agency's decisions on exclusivity periods; competitors' ability to extend exclusivity periods past initial patent terms; that IVAX may not receive approval of its pending ANDAs, or that if approved, the products will not be successfully commercialized; that IVAX may not file any additional ANDAs; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Neurontin(R) is a registered trademark of Warner-Lambert Company, a unit of Pfizer Inc.