Thursday 18 December, 2008

Clarinex (Desloratadine): Lupin settled patent dispute with innovator

Indian Pharma compnay Lupin has settled a patent dispute with innovator Schering-Plough Corp. over that company's allergy drug Clarinex (Desloratadine).
Under the settlement, Lupin said it would be able to sell a generic version of the drug starting July 1, 2012.
Earlier, innovator Schering sued Lupin for patent infringement of US6100274 (which covers Stable formulation), US7214683 (which covers formulation of descarboethoxyloratadine) and US7214684 (method of use of descarboethoxyloratadine) based upon its filing of an ANDA containing a Paragraph IV certification.
Earlier, innovator had sued various generic players like Zydus, Sandoz, Mylan, Orchid, Perrigo, Glenmark, GeoPharma, Lupin, Ranbaxy, Sun, Watson, Dr. Reddy's who filed ANDA to market this product. Importantly, Innovator has patents listed in orange Book with expiries in 2020. Apart from Lupin, innovator had settled with Perrigo, Watson Pharma and Ranbaxy. Possibly, all generic players are in licensing agreement with Innovator

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