Apotex Generics Company Intelligence Report

Date: January 22, 2011
Pages: 20
US$ 340.00
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: A6B5B264394EN

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Apotex Generics Company Intelligence Report
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.




Apotex ANDA Approvals, January 2002 – September 2010
Second and last Apotex CAMR shipment leaves for Rwanda
Plavix (clopidogrel)
sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action
sanofi-aventis wins Canadian clopidogrel patent case against Apotex
Apotex overturns Australian clopidogrel patent
Recent product approvals
Losartan and losartan / hydrochlorothiazide (US)
Atorvastatin (Canada)
CHMP adopts positive opinion on Apotex olanzapine product


Cangene: Fiscal Year Results, in C$000s
Cangene: Fiscal Year Results, in US$000s
Biopharmaceutical operations
Cangene: Biopharmaceutical Operations Fiscal Year Results, in C$000s
Cangene: Biopharmaceutical Operations Fiscal Year Results, in US$000s


Apotex receives FDA warning letter
Mergers, acquisitions and agreements
Apotex sells group of products to AA Pharma
Apotex signs fentanyl agreement with Hisamitsu
Cangene acquires US commercialisation rights for HepaGam B
Appellate court upholds budesonide injunction against Apotex
Mylan to appeal court paroxetine decision
Daiichi Sankyo settles cevimeline patent litigation with Apotex
AstraZeneca loses Canadian generic esomeprazole NOC request
Rosuvastatin patent upheld in court
Allergan sees brimonidine patent infringement victory
Unigene's Fortical patent valid

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