Pfizer locks horns with generics manufacturers
Pfizer has filed a Citizen Petition with the US Food and Drug Administration (FDA) claiming that azithromycin products, generic versions of its Zithromax antibiotic, sold by Teva Pharmaceuticals USA and Sandoz, the generic arm of Novartis, 'appear to be misbranded because their labels do not accurately describe the drugs' active ingredients'.
Pfizer has filed a Citizen Petition with the US Food and Drug Administration (FDA) claiming that azithromycin products, generic versions of its Zithromax antibiotic, sold by Teva Pharmaceuticals USA and Sandoz, the generic arm of Novartis, 'appear to be misbranded because their labels do not accurately describe the drugs' active ingredients'.
It has also brought patent infringement actions against the two companies, claiming that their products violate a recently issued patent covering azithromycin sesquihydrate as they contain 'significant amounts' of azithromycin sesquihydrate, rather than the azithromycin monohydrate stated in their labels.
Teva has called the allegations 'baseless and without merit' and branded Pfizer's actions 'a thinly veiled attempt to discredit Teva and the entire generic drug industry, which have been providing affordable, safe pharmaceutical products to patients for decades'.
A Teva statement reads: 'Teva's azithromycin is a self developed product and is protected by US Patent No 6,365,574, issued and assigned to Teva on 2 April 2 2002. Teva's proprietary process for the manufacture of azithromycin monohydrate predates Pfizer's US Patent No 6,977,243 ('the sesquihydrate patent') regarding the sesquihydrate form of the product.
'The final product contains azithromycin monohydrate as stated on the label and as approved by the FDA.'
Pfizer believes that its claims should result in an FDA recall of the products in order 'to correct their misbranding' and 'review the product approval applications filed by the two companies to ensure the information contained within them is accurate and complete and, if not, to take appropriate remedial action'. It is requesting that the court in the patent case 'impose preliminary and permanent injunctions against further sales of the drugs'.
Zithromax accounted for over $2.0bn of Pfizer's $51.3bn revenue in 2005. Teva and Sandoz launched their generic versions in November 2005.
In December 2005, Pfizer prevailed in its patent dispute with India's Ranbaxy Laboratories over its cholesterol-lowering drug Lipitor. The world's top-selling drug, it scored sales of $12.2bn in 2005.