The US Food and Drug Administration (FDA) has granted final marketing approval to Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) for generic Zoloft (Sertraline). Pfizer Inc. (NYSE:PFE; LSE:PFZ), the maker of the anti-depressant, is challenging Teva by marketing its own authorized generic version of the drug. The FDA approved 25mg, 50mg, and 100mg Sertraline tablets for Teva.
Teva will enjoy a 180-day marketing exclusivity for generic Zoloft. Teva plans to begin sales towards the end of July. The company added that Zoloft had $3 billion in US sales in the 12 months to March 2006.
Last month, close to Teva’s launch of generic Zocor, an anti-cholesterol drug made by Merck & Co. (NYSE:MRK), Merck promised to cut the price of original Zocor in a way that will challenge Teva’s 180-day marketing exclusivity for generic Zocor, in a move that created uncertainty in the generic drug industry.
Clal Finance Batuch analyst Yasca Erez said the Zoloft case did not resemble the “Zocor War”.
Published by Globes [online], Israel business news - www.globes.co.il - on July 2, 2006
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