Lupin settles Alzheimer drug litigation with Forest Laboratories

Pharma major, Lupin announced today that it has settled all ongoing Hatch Waxman litigation relating to memantine tablets, Lupin's generic version of Forest Laboratories, Alzheimer disease treatment "Namenda" tablets. As per the terms of the settlement, Lupin will be licensed under the relevant patents and would be free to commercially launch its generic product in Jan 2015 or earlier in certain circumstances. Lupin had earlier filed a Paragraph IV certification to US Patent No 5,061,703, contesting that the patent was invalid or had not been infringed, resulting in the subsequent litigation with Forest.

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.

Oscient and Ethypharm receive paragraph IV notification from Lupin for Generic fenofibrate

Oscient Pharmaceuticals Corporation and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg doses. The notice alleges that U.S. Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for ANTARA, is invalid and/or will not be infringed by Lupin's manufacture, use or sale of the product for which the ANDA was submitted. U.S. Patent No. 7,101,574 is set to expire in 2020. Oscient and Ethypharm have 45 days to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision in its favor, whichever may occur earlier. Oscient and Ethypharm are currently in the process of evaluating the notice from Lupin and intend to pursue all available legal and regulatory options in defense of ANTARA, including enforcement of their intellectual property rights.

IPblogger will provide update on the developments time to time....