MUMBAI, India, Dec. 17 Pharma Major, Lupin Ltd. announced today that it has settled all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough's "Clarinex"(R) tablets.
As per the terms of the settlement, Lupin Ltd. 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, U.S. 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(R) tablets had U.S. sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.
Commenting on the settlement, Dr. Kamal Sharma, Managing Director, Lupin said - "The settlement with Schering-Plough leaves us strategically poised to further strengthen, consolidate and grow our market position in the U.S. markets. Furthermore, the settlement, recent product approvals and growth in filings across markets are a testament to our increased strengths and focus on Research & Development and the quality of our Intellectual property - a testimony to Lupin's larger goal of developing and delivering quality, cost-effective drugs for everybody."
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs. The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
Currently positioned amongst the top six pharmaceutical companies of India, the Company is committed to achieve sustainable earnings and growth for all its stakeholders. For the financial year ended March 2008, the Lupin's Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 million), respectively.
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SOURCE Lupin Ltd.