Novartis has lately filed a civil lawsuit against the Mumbai-based generic manufacturer Macleods Pharmaceuticals Limited for infringement of US Patent No. 5,866,581 listed with the Orange Book for Famvir tablets, generically Famciclovir. The lawsuit is filed in the US District Court for the District of Columbia in response of Macleods submission to the FDA an abbreviated new drug application (ANDA) seeking approval to market generic Famciclovir 125mg, 250mg and 500mg tablets before the expiration of the ‘581 patent. With this development, Macleods is another Indian company that joined the league of Paragraph IV challengers from India
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