Generic player Geopharm announced (in a press release Here) that it would be able to commercially launch a generic version of the anti-allergy drug Desloratadine (Clarinex) in United States after settling pending patent litigation. Geopharm is 6th generic player, who has settled the pending patent litigation on Clarinex.
Specific financial terms and conditions of the settlement agreement were not disclosed, but it allows GeoPharma to receive a license under all relevant patents, the release said.
GeoPharma will launch its generic Desloratadine version, with six months marketing co-exclusivity, on July 1, 2012, or earlier in certain circumstances. The new product launch can be a prescription or Over-The-Counter (OTC) product, depending on its status at the time of launch. Earlier, innovator Schering sued Geopharm for patent infringement of following patents based upon its filing of an ANDA containing a Paragraph IV certification:
Specific financial terms and conditions of the settlement agreement were not disclosed, but it allows GeoPharma to receive a license under all relevant patents, the release said.
GeoPharma will launch its generic Desloratadine version, with six months marketing co-exclusivity, on July 1, 2012, or earlier in certain circumstances. The new product launch can be a prescription or Over-The-Counter (OTC) product, depending on its status at the time of launch. Earlier, innovator Schering sued Geopharm for patent infringement of following patents based upon its filing of an ANDA containing a Paragraph IV certification:
US6100274: Which covers Stable formulation
US7214683: Which covers formulation of Descarboethoxyloratadine
US7214684: Method of use of descarboethoxyloratadine
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 Geopharm, innovator had settled with Perrigo, Watson Pharma and Ranbaxy,
Apart from Geopharm, innovator had settled with Perrigo, Watson Pharma and Ranbaxy,
Dr. Reddy, Lupin. Possibly, all generic players are in licensing agreement with Innovator and would launch generic around July, 2012.
Earlier news of IP Pharma Doc on Desloratadine Here
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