Lupin settles antidepressant drug litigation with Wyeth

Wins exclusive rights to Effexor XR for 180 days beginning June 2011.

Lupin, a generic drug maker, has settled all patent litigation with US drug maker Wyeth for Effexor XR capsules, the US firm’s branded anti-depressant.

“According to the terms of the 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. Under certain circumstances, the Indian drug-maker can also launch the product five months earlier (January 1, 2011).

“The settlement with Wyeth is in line with our growth strategies and will help us further strengthen our product pipeline and build strong market positions in the US,” said Kamal Sharma, managing director, Lupin.

Venlafaxine is the generic name of Wyeth’s blockbuster anti-depressant drug, Effexor XR. The original licence-holder, Wyeth, reported sales of $3.01 billion for Effexor XR in 2008, acccording to the statement by Lupin. The drug accounted for 17 per cent of Wyeth’s revenues last year. The company didn’t provide financial details of the settlement.

Lupin had challenged Wyeth’s US patents on Effexor XR under the Hatch-Waxman Act, which allows copycat drug-makers to challenge the patents granted to original owners. If the challenger wins, it gets exclusive rights to sell the drug for 180 days.

As Wyeth’s product patent on venlafaxine, the key ingredient in the drug, expired in 2008, Lupin challenged Wyeth’s US patent Nos 6,274,171, 6,403,120 and 6,419,958. The Indian firm said these patents were either invalid or had not been infringed. This resulted in the subsequent litigation by Wyeth.

The original patent holder contended that Lupin would be infringing on the three patents, which are slated to expire in 2017.