Generic player Orchid and innovator Schering-Plough (now, subsidiary of Merck) have settled the patent litigation relating to Desloratadine tablets, 5 mg and Desloratadine 2.5 mg and 5 mg orally disintegrating tablets (ODT).
These are generic versions of Schering's Clarinex and Clarinex Reditabs for allergy medication. The litigation has been pending in the US, District Court of New Jersey since September 2006.
Pursuant to the settlement, Orchid will have the right to market desloratadine tablets 5mg and desloratadin 2.5 mg and 5 mg orally disintegrating tablets in the US from July 1, 2012 and January 1, 2012 respectively after approvals from US FDA. Orchid's products may be the prescription form or over-the-counter version products depending on the status of Clarinex and Clarinex Reditabs at the time.
Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.
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 Mylan, innovator had settled with Geopharm, 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.
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