Anchen obtained approval of its generic Wellbutrin XL product, and in accordance with this agreement, selectively waived its 180-day period of marketing exclusivity in favor of IMPAX Laboratories. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate IVAX Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra([R]), Neurontin([R]) and Zithromax([R]), the effects of competition on Copaxone([R]) sales, including as a result of the reintroduction of Tysabri([R]) into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U. The patent estate protecting Wellbutrin XL(R) consists of two formulation patents (U. Pursuant to Teva's existing strategic alliance agreement with IMPAX, Teva has U.
IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information about Biovail, visit the company's Web site at www. Biovail also filed suit in the United States District Court For The Southern District of Florida against Abrika Pharmaceuticals LLLP, which has submitted an ANDA for a generic 150mg version of Wellbutrin XL(R). "In addition, generic Wellbutrin XL is the first of our Tier 3 products to be marketed under the 12-product Strategic Alliance Agreement signed 300 mg wellbutrin xl with Teva in July 2001. Marketing 300 mg wellbutrin xl rights to IMPAX's version of this product. Additionally, where strategically 300 mg wellbutrin xl appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. Anchen has been granted summary judgment of noninfringement with regard to its product.
If a legal patent infringement suit is commenced within 45 days from receipt of the Notice of Non-Infringement, pursuant to the provisions of the Hatch-Waxman legislation, the FDA cannot approve the generic product for up to a period 300 mg wellbutrin xl of 30 months or upon a Court decision of non-infringement -- whichever is earlier. "Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995 To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements 300 mg wellbutrin xl within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The active ingredient in Wellbutrin XL(R) - bupropion hydrochloride - is believed to act upon norepinephrine and dopamine, two chemicals in the brain known to help regulate different aspects of mood, cognition, and behavior.
Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for each of the first three quarters of 2006, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and 300 mg wellbutrin xl pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Biovail Corporation undertakes 300 mg wellbutrin xl no obligation to update or revise any forward-looking statement. NORTH WALES, Pa. Contact GlaxoSmithKline, 300 mg wellbutrin xl 888-825-5249, www.Com/ products / wellbutrin_us. TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that Biovail 300 mg wellbutrin xl laboratories Inc. Biovail anticipates the issuance of this new patent by mid-2005. Teva will record the revenues resulting from sales of the product and remit payments 300 mg wellbutrin xl to Anchen and a negotiated percentage of its gross profit to IMPAX. Douglas Squires, 300 mg wellbutrin xl biovail's Chief Executive Officer.