Lupin reaches settlement with Wyeth on patented drug

13 May 2009

Pharmaceutical company Lupin Ltd, which makes generic drugs,   has settled all ongoing litigation with Wyeth relating to Venlafaxine extended release capsules.

Under the settlement, the Indian company will be licensed to launch a copycat version of the drug patented by Wyeth in the US after 1 June 2011, Lupin said in a statement to stock exchanges. Under limited circumstances the Indian drug-maker can also launch the product five months earlier.

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 Lupin's statement. The drug accounted for 17 per centof 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 under the 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 two of Wyeth's US patents, contesting that these were either invalid or had not been infringed. This had resulted in the subsequent litigation by Wyeth

relating to its Venlafaxine capsules.

Wyeth's Effexor XR capsules had U.S. sales of $3.01 billion in 2008, Lupin said, citing data from market research firm IMS Health. The company didn't provide financial details of the settlement.