After nearly three years of fighting in the US District Court, New Jersey, Orchid Chemicals & Pharmaceuticals Ltd on Wednesday announced the settlement of patent litigation with US-based Schering-Plough relating to Desloratadine tablets (5 mg) and Desloratadine (2.5 mg and 5 mg) orally disintegrating tablets, the generic versions of the US company’s Clarinex and Clarinex RediTabs.
Schering-Plough is the innovator of the said products. These products together hold a market potential of over $350 million annually.
Pursuant to the settlement, Orchid will have the right to market Desloratadine tablets in the US markets from January 2012 onwards or earlier in certain circumstances provided the US FDA approves the its abbreviated new drug applications of above products.
When contacted, Orchid’s spokesperson said: ?The company has patent disputes with the same company over seven products. Of which, two have been settled now. We hope the remaining will be taken up as and when the products go off-patent.?
According to him, Orchid’s products may be the prescription form or over-the-counter version, 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 justic and the Federal Trade Commission.
According to Schering-Plough, all pending patent infringement litigations filed since 2006 in the US District Court, New Jersey, by the company against Orchid had been resolved.