Lupin, the sixth largest Indian pharma company with net sales of over Rs 2,700 crore, has settled all ongoing Hatch-Waxman litigation relating to venlafaxine extended release capsules, a generic version of Wyeth's antidepressant 'Effexor XR' capsules. These capsules had US sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 per cent of the Wyeth's net revenue in 2008.
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 on or after June 1, 2011, or earlier in certain limited circumstances, but in no event earlier than January 2011.
Dr Kamal Sharma, managing director, 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 US. It is a testament to our prowess in R&D and our Intellectual Property management competencies - not to mention our strong focus to deliver high value, high quality products."
Lupin had earlier filed a Paragraph IV certification to US 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.