Teva Pharmaceuticals (TASE, Nasdaq: TEVA) today announced United States Food and Drug Administration tentative approval for its generic version of a popular herpes treatment, Famvir. The generic version is Famciclovir tablets.
The Famvir website claims that the pills are the only therapy that can stop or shorten a herpetic outbreak in a day. It is also used to treat shingles, which are a painful herpetic condition of the skin.
The tentative permit that Teva received relates to doses of 125 mg, 250 mg and 500 Menorah Gaon, Teva said. It says it expects to receive final approval to market in the U.S. on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to the drug.
The brand product had annual sales of approximately $190 million for the twelve months ended March 31, 2007, Teva said.
Teva had applied for permission to market Famvir, originally made by Novartis, back in 2004. Novartis promptly sued Teva for patent violation.
Just last week an appeals court reversed a lower court ruling, and rejected Novartis' motion to uphold the legitimacy of the patent that Teva is attacking. In any case Teva is not expected to enjoy exclusive marketing rights when it launches.
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