| May 11, 2009, Mumbai, India Pharma Major, Lupin Ltd. announced today that it has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules, Lupin’s generic version of Wyeth’s antidepressant “Effexor XR®” capsules.
As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product on or after 1st of June, 2011, or earlier in certain limited circumstances, but in no event earlier than January 1, 2011.
Lupin had earlier filed a Paragraph IV certification to U.S. Patent Nos. 6,274,171, 6,403,120 and 6,419,958, contesting that these patents were either invalid or had not been infringed.- resulting in the subsequent litigation by Wyeth.
Wyeth’s “Effexor XR®” capsules had U.S. sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 percent of the company’s net revenue last year.
Commenting on the settlement, Dr. Kamal Sharma, Managing Director, Lupin said - “The settlement with Wyeth is in line with our growth strategies and would help us further strengthen our product pipeline and build strong market positions in the U.S. It is a testament to our prowess in Research & Development and our Intellectual Property management competencies - not to mention our strong focus to deliver high value, high quality products.”
About Lupin Limited
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generics, branded formulations and APIs for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs. The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
Currently positioned amongst the top five pharmaceutical companies of India, the Company is committed to achieve sustainable earnings and growth for all its stakeholders.
For the financial year ended March 2008, the Lupin's Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 million) respectively.
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