Lupin settles desloratadine lawsuit with Schering-Plough

Lupin Ltd has announced that the company has settled all ongoing Hatch-Waxman litigation relating to desloratadine tablets, the generic version of Schering-Plough's 'Clarinex' tablets. As per the terms of the settlement, Lupin will be licensed under the relevant desloratadine patents, and free to commercially launch its generic desloratadine product, on July 1, 2012, or earlier in certain circumstances.

Lupin had earlier filed a Paragraph IV certification to, among others, US Patent Nos. 6,100,274, 7,214,683 and 7,214,684, contesting that these patents were either invalid or had not been infringed upon - resulting in the subsequent litigation by Schering Corp. and Sepracor. Schering-Plough's Clarinex tablets had US sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

Perrigo can commrecially launch desloratadine after settlement of patent litigation

All Hatch-Waxman litigations relating to Perrigo's Desloratadine tablets (5 mg) has been settled with Perrigo taking a license under all relevant patents. Perrigo had been sued for patent infringement of US Patent Nos. 6100274, 7214683 and 7214684 based upon its filing of an ANDA containing a Paragraph IV certification. As per the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or OTC product depending on its status at the time of launch. The Perrigo product is awaiting FDA approval. Perrigo's generic seeks an AB-rating as equivalent to Schering-Plough's Clarinex(R) tablets (5 mg) indicated for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. Sales for the brand were approximately $300 million, according to Wolters Kluwer data for the twelve months ending October 2008.