Pfizer Inc has petitioned the FDA to recall azithromycin products sold by Teva Pharmaceuticals U.S.A. and Sandoz Inc. that are generic versions of Pfizer’s antibiotic, Zithromax(R), claiming mislabeling of the packaging. The US patent for Zithromax expired in November 2005.
Pfizer has also brought patent infringement actions against both companies, claiming infringement of a patent covering azithromycin sesquihydrate, alleging that the drugs contain significant amounts of azithromycin sesquihydrate rather than the azithromycin monohydrate as claimed in the labeling.
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Pfizer is using baseless patents to just extent their patent position and attack generic companies.
The patent is extremely clever because it has taken the chromatograph of monohydrate and just created sesquihydrate on that same peak. This way its very hard to differentiate btw mohohydrate and sesquihydrate