FORT LEE, N.J., Feb. 11 /PRNewswire-FirstCall/ -- Alpharma Inc. , a leading global generic pharmaceutical company, today announced it had entered into a settlement agreement regarding the Ivax Pharmaceuticals, Inc ("Ivax") litigation challenging the company's exclusivity regarding gabapentin capsules and tablets. Ivax had filed an appeal in the United States Court of Appeals for the District of Columbia seeking to reverse a District Court decision upholding Alpharma's right to exclusivity for gabapentin capsules and tablets. In consideration for Ivax's agreement to dismiss the litigation, the company has agreed to allow Ivax to enter into the gabapentin capsule and tablet markets on March 23, 2005 and April 29, 2005, respectively, prior to the lapse of the company's first-to-file exclusivity period. The company's exclusivity on gabapentin capsules and tablets expires on April 6, 2005 and June 11, 2005 respectively. Filing the selective waivers in favor of Ivax is contingent upon the Court entering an order dismissing Ivax's appeal, which has not yet occurred. Until the company's selective waivers become effective on the dates indicated above, and Ivax obtains its final approvals, however, Ivax shall continue to be prohibited from marketing its gabapentin capsule and tablet products. The company expects the impact of this agreement to reduce its sales of gabapentin during the exclusivity period.
In addition, the company has amended its previously disclosed agreement with Teva Pharmaceutical Industries regarding gabapentin to allow for the selective waiver. The key elements of the profit sharing arrangement and litigation indemnification contained in the agreement remain essentially unchanged despite the entrance of Ivax into the market. These amendments are also subject to the issuance of the Court's order of dismissal.
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Alpharma Inc. is a global generic pharmaceutical company with leadership positions in products for humans and animals. Uniquely positioned to expand internationally, Alpharma is presently active in more than 60 countries. Alpharma is a leading manufacturer of generic pharmaceutical products in the U.S., offering solid, liquid and topical pharmaceuticals. It is also one of the largest suppliers of generic solid dose pharmaceuticals in Europe, with a growing presence in Southeast Asia. Alpharma is among the worlds leading producers of several important pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry, swine and cattle.
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