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Apotex Generics Company Intelligence Report
Espicom Business Intelligence Ltd, Jan 2011, Pages: 20
Apotex is active in around 115 countries, and has subsidiaries, joint ventures or licensing agreements in Asia, Europe and Latin America. Products are sold under the Apotex brand, and under customer brand names.
In 2006, Apotex received an ANDA approval for clopidogrel bisulphate, the generic form of sanofi-aventis’ Plavix. In a lucrative but controversial and potentially very risky move, Apotex launched its version in August 2006 without waiting for the attendant legal issues to be resolved. Apotex lost the case in July 2007.
In 2007, Apotex became the first company to attempt to utilise Canada’s Access to Medicines Regime, amending Canada’s patent regime to enable generic firms to produce copies of patented drugs for use in least-developed nations. Apotex is to manufacture an antiretroviral fixed dose combination drug for Rwanda, which has raised the request through the framework of the World Trade Organisation’s TRIPS agreement. In May 2008, Apotex got the final go ahead to begin production. However, the company has since suggested that it would not be willing to undergo the process again, as it was too difficult. The final shipment occurred in September 2009.
Through Cangene, Apotex is active in the biosimilar area. One product, Leucotropin, is under review in Canada, while in the USA, Accretropin was approved in January 2008, but has not been marketed. In April 2008, Apotex entered an agreement to develop Neukine, a recombinant G-CSF, with INTAS Biopharmaceuticals for the European market.
In March 2010, the FDA issued Apotex with a Warning Letter, following an inspection of the firm's Toronto facility in the summer of 2009. This followed an Import Alert issued by the FDA in September 2009, following an earlier Warning Letter regarding an inspection of Apotex' Etobicoke facility.
Executive Summary
Espicom's generics company reports will help you to understand the dynamic and complex issues affecting the business of leading generic industry players. These informative reports provide an insight into the company, covering the structure of the business, the most recent quarterly and annual financial results, information on the company's active product lines and ANDA approvals, along with a review of major developments, such as M&A activity, strategic alliances, and litigation.
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