Teva gains tentative approval for generic atorvastatin

Generics/News | Posted 13/01/2012 post-comment0 Post your comment

Teva announced on 1 December 2011 that it had received tentative approval from FDA for its generic version of Pfizer’s blockbuster cholesterol-reducing medication Lipitor (atorvastatin).


The approval will allow Israel-based Teva to enter the lucrative Lipitor market at the end of Ranbaxy Laboratories’ 180-day first-to-file exclusivity period in May 2012. With such a lucrative product, many generics manufacturers are expected to market atorvastatin generics once Ranbaxy’s exclusivity period ends, pushing down generics prices and eroding Pfizer’s sales of brand-name Lipitor.


Teva is on to a win–win here, as the generics giant will also receive a portion of rival Ranbaxy’s profits from sales of generic atorvastatin during the 6-month exclusivity period [1].


Pfizer is not giving up easily though and is fighting back with a number of different measures. Even before the patent expired on Lipitor on 30 November 2011, and in an attempt to increase brand loyalty, Pfizer was offering the brand-name drug at highly discounted prices to patients through co-payment cards and deals with drug–benefit plans. The company has also been offering discounts to pharmacists in return for blocking generics to try to retain some of its market share and has stated that it intends to offer Lipitor at or below the cost of generic atorvastatin during the 180-day exclusivity period [2].


Pfizer’s actions, however, have attracted criticism from US senators, who have questioned the approach as a way for drug–benefit companies to ‘abuse Medicare to boost their profits’ and as an attempt to push generics out of the market, thereby ‘denying generics alternatives to patients’.


The stakes are high. Lipitor had sales of US$10.8 billion in 2010 alone and has been the world’s best-selling drug for the last 10 years, generating 27% of Pfizer’s income [1].


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1. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy gets FDA approval and launches generic atorvastatin []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from:


2. GaBI Online - Generics and Biosimilars Initiative. Pfizer continues to fight for Lipitor []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from:

Source: Teva, US Senate

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