Pfizer Sues Teva, Sandoz Over Zithromax

NEW YORK – Pfizer Inc. has filed a patent infringement suit against generic drug makers Teva Pharmaceutical Industries Ltd. and Sandoz Inc. concerning generic versions of the antibiotic Zithromax.

Representatives from Sandoz, based in Princeton, N.J., and Teva, based in Israel, couldn’t immediately be reached for comment.

In a press release Wednesday, Pfizer also said it filed a petition with the U.S. Food and Drug Administration, claiming Teva’s and Sandoz’s azithromycin product labels do not accurately describe the drug’s active ingredients.

According to Pfizer, the generics contain significant amounts of azithromycin sesquihydrate, rather than the azithromycin monohydrate that their labels state.

Pfizer’s Zithromax and generic azithromycin, launched by the company’s Greenstone subsidiary, contain azithromycin dihydrate, which is the product approved in Pfizer’s new drug application.

Pfizer, based in New York, is asking the FDA to recall the drugs and review the product approval applications filed by the two companies.