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IVAX Launches Gabapentin Tablets
Business Wire, August 18, 2004
MIAMI -- IVAX Corporation (AMEX:IVX)(LSE:IVX.L) announced today that it has commenced the initial commercialization of its gabapentin tablets in 100 mg, 300 mg and 400 mg strengths to selected customers. IVAX received final approval of its Abbreviated New Drug Application for these tablets from the FDA in April 2004. As the first company to file an ANDA with a Paragraph IV patent certification, IVAX has been awarded 180-days marketing exclusivity for the tablet form of the product in the above sizes. Gabapentin is the generic name of Neurontin(R), approved to treat seizures and postherpetic neuralgia (PHN), and is marketed by Warner-Lambert, a unit of Pfizer Inc. Neurontin had U.S. sales of approximately $2.4 billion in 2003.
Related Results
Neurontin is sold by Warner-Lambert in 5 dosage strengths: 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. It is the 100 mg, 300 mg and 400 mg tablets, not currently marketed, that IVAX intends to market through its U.S. generics subsidiary, IVAX Pharmaceuticals, Inc.
IVAX received a tentative approval from the FDA for its ANDA for the 100 mg, 300 mg, and 400 mg capsules, and on the 600 mg and 800 mg tablets marketed by Warner-Lambert. Litigation with Pfizer concerning the Neurontin patent is pending and a trial has not yet been scheduled.
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 www.ivax.com.
The "FDA" refers to the United States Food and Drug Administration.
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 tablets in 100 mg, 300 mg and 400 mg dosage strengths may be delayed or may be stopped at any time; that the products will not be successfully commercialized; that market acceptance for the tablet dosage form of gabapentin may not as anticipated; 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; that the patent litigation with respect to these products could prevent us from selling these products, could result in substantial damages which could exceed the expected profit or selling price for these products; 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 final approval of IVAX' ANDA for the 100 mg, 300 mg and 400 mg capsules and the 600 mg and 800 mg tablets may be delayed or not received at all, and that if finally approved, the products will not be successfully commercialized; that IVAX may not increase the number of products in its generic portfolio; 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.
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