Lupin has settled all ongoing with Wyeth relating to Venlafaxine extended release capsules.
"As per the term of settlement, Lupin will be licensed to launch a copycat version of the drug in the US after June 1, 2011," Lupin said in a statement issued to stock exchanges. Under limited circumstances the Indian drug-maker can also launch the product 5 months earlier (January 1).
Venlafaxine is the generic name of Wyeth's blockbuster antidepressant drug sold under the brand name Effexor XR. The original license-holder, Wyeth, reported $3.01 billion worth of sales for Effexor XR in the year 2008, as per the statement released by Lupin. The drug accounted for 17% of Wyeth's revenues last year.
Commenting on the settlement, 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 US."
Lupin had challenged Wyeth's US patents on Effexor XR, as per Hatch-Waxman Act. This act allows copycat drug-makers to challenge the patents of original owner. If they win, the challenger gets exclusivity to sell the drug for a period of 180 days.
Lupin had challenged to Wyeth's US patent No 6,274,171, 6,403,120 and 6,419,958. The Indian pharma contested that these patents were either invalid or had not been infringed. This had resulted in the subsequent litigation by Wyeth.