Global Clopidogrel Bisulfate
Industry is a professional and the deep research report in this field.
PM103 is a proprietary, novel intravenous formulation of clopidogrel bisulfate
8 billion for the quarter compared to 2006, due to the continued growth of our key products and sales of newer products, mostly offset by the impact of generic clopidogrel bisulfate
and increased generic competition for PRAVACHOL.
The Court also ruled that Apotex's generic clopidogrel bisulfate
infringes sanofi-aventis' patent, and has enjoined Apotex from marketing this product in the United States until the patent expires.
The reformulation of clopidogrel bisulfate
is an example of the potential for Acusphere's proprietary Hydrophobic Drug Delivery System (HDDS[TM]) technology to create intravenous formulations of drugs that are currently only available in oral dosage form.
The company expects generic clopidogrel bisulfate
that was sold into distribution channels following the Apotex at-risk launch in August 2006 will continue to have a declining residual impact on PLAVIX(R) net sales and the company's overall financial results at least through the second quarter of 2007.
Under the terms of the agreement, Apotex would receive from Sanofi-aventis a royalty-bearing license under the '265 patent to manufacture and sell a generic clopidogrel bisulfate
product in the United States.
The decrease in non-GAAP net earnings in 2006 as compared to 2005 is mainly due to the impact of the at-risk launch of generic clopidogrel bisulfate
in August 2006, which continued to have a significant adverse effect in the fourth quarter, and the loss of patent exclusivity on PRAVACHOL(R) in major markets.
s ("Apotex") appeal of the judgment of the Federal Court of Canada prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in connection with its 75mg clopidogrel bisulfate
The injunction ordered Apotex to halt its sales of a generic version of clopidogrel bisulfate
that competes with PLAVIX(R) pending the District Court's decision in the trial on the merits.
THIRD QUARTER: - Third quarter of 2006 hit by the launch of a generic version of clopidogrel bisulfate
in the United States on August 8, 2006, and by measures to curb healthcare costs in France and Germany.
The decrease in non-GAAP net earnings in 2006 as compared to 2005 is mainly due to the impact of an at-risk launch of generic clopidogrel bisulfate
, the loss of patent exclusivity on PRAVACHOL(R) in major markets and increased investments behind the development of new products.
These risks and uncertainties include risks that may arise from the Department of Justice's criminal investigation on the Plavix(R) proposed settlement with Apotex, the adverse impact of generic product distributed into the market prior to the Court's injunction, the risks related to the launch of a generic clopidogrel bisulfate
product by Apotex, the potential launch of a generic clopidogrel bisulfate
product by other entities, as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005.
Apotex") to halt its sales of a generic version of clopidogrel bisulfate
product that competes with PLAVIX(R).
Apotex") announced that it was launching at risk in the United States a generic clopidogrel bisulfate
product that competes with PLAVIX(R), a product marketed jointly by sanofi-aventis and Bristol-Myers Squibb .