NEW YORK Wyeth faces an uphill struggle to protect patent exclusivity for its blockbuster drug Protonix after Teva Pharmaceutical Industries Ltd. launched a generic version of the heartburn pill in the U.S. market, according to published sources.
The Israeli company had already won Food and Drug Administration for its generic, pantoprazole, approval over the summer, and had also recently seen Wyeth fail to win a preliminary injunction from a federal judge against the launch of the drug—though it is appealing the decision.
Some analysts, the Wall Street Journal reported, said the launch puts pressure on Wyeth to settle with Teva to allow marketing of a generic pill before the patent expires. However, a pre-expiry launch of this kind carries much risk along with the payoff, as a finding against Teva could cost the company as much as three times the damages to Wyeth that the launch caused. Protonix showed sales figures of $1.45 billion during the first nine months of 2007.
But Teva stated Monday that it believes it has the upper hand in the legal battle and thinks the risk for excessive damages is low. The company has agreed to refrain from shipping additional quantities of the drug during the standstill period, which expires Jan 22.