180-day exclusivity for Teva's famotidine

5 June 2001

Teva Pharmaceutical Industries has been awarded final approval by the USFood and Drug Administration for its 10mg famotidine tablets for the treatment and prevention of heartburn, which will be marketed through an alliance with Perrigo Company. Teva will have a 180-day market exclusivity period for this formulation, which is expected to be launched immediately.

Teva's drug is a generic version of Merck & Co's Pepcid (famotidine), which finally lost patent protection in the USA earlier this year, but which had turnover in 2000 of $569 million (Marketletter April 23). Annual sales of Teva's product in the USA are estimated to be $125 million.

Teva will face competition from other pharmaceutical companies, including Mylan, which received a tentative approval from the FDA to market 20mg and 40mg famotidine tablets (Marketletter February 12), IVAX Laboratories and Pharmaceutical Resources' subsidiary Par Pharmaceutical, which have indicated that they will immediately launch generics. Merck also released a new formulation, Pepcid Complete (famotidine and calcium carbonate) last year, to help reduce the impact of the patent expiry.

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