Thursday, 20 May 2010

Generic version of Atorvastatin Calcium tablets approved and launched in Canada

Various generic players have received the Notice of Compliance from Health Canada to market generic version of Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets in Canadian market.

The generic players like a) Apotex, b) Pharmascience, c) Teva, d) Sandoz, e) Watson, F) Cobalt, g) NovoPharm and h) Ratiopharm have received Notice of Compliance letters on this blockbuster formulation on May 19, 2009 (as per Health Canada website).

Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets had annual brand sales of approximately C$1.3 billion in Canada.

Innovator Pfizer has a key patent CA2021546 (Expiry: July 19, 2010), the said patent covers enantiomer of Atorvastatin as product. The various generic players have litigated with innovator on this patent and subsequently generic players settled with innovator (in Aug, 2008). As per press releases, 3 generic players namely Apotex, Teva and Watson have confirmed about the generic launch in the Canadian market. Importantly, these generic players have been able to enter into the Canadian market exactly 2 months before the blocking patent's expiry.

Further, generic players like Apotex, Teva and Watson have announced about the generic launch of this formulation in the following press releases:

Teva Press Release: http://www.tevapharm.com/pr/2010/pr_935.asp

Watson Press Release: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1429149

News about Ranbaxy's generic version: http://www.digitaljournal.com/pr/39611

Reuters news on the generic launch: tp://www.reuters.com/article/idUKN1924176320100519?type=companyNews

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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