Lupin has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules with Wyeth. Lupin’s Venlafaxine capsules are the generic version of Wyeth’s Effexor XR capsules. Effexor XR is the world’s best selling antidepressant. According to Wyeth’s financial results, the annual sales of Effexor XR capsules is around USD 3.9 billion for the year 2008 and accounted for 17% of the Wyeth’s net revenues. Under the terms of the settlement, Lupin can launch Venlafaxine capsules on or after 1st June 2011 or earlier in certain limited circumstances, but in no event earlier than 1st January 2011.
Lupin had earlier filed a Paragraph IV certification to US Patent Nos 6274171, 6403120 and 6419958, citing that these patents were either invalid or had not been infringed, upon which Wyeth filed a lawsuit against Lupin. Earlier to Lupin, Wyeth has also settled patent litigation with two International players (Impax and Teva Pharmaceutical) for the same drug on similar conditions.