Altana Pharma AG and Wyeth v. Teva Pharms. USA, No. 04-2355 (D.N.J. 2007)
Last Thursday, a federal district court denied Wyeth’s motion for a preliminary injunction that would have prevented generic drug manufacturer Teva from launching its generic version of Protonix. The opinion denying Wyeth's motion was filed under seal; only the order is publicly available currently.
Wyeth amassed $2.5 billion in sales of the heartburn medication for the sales year ending on June 30, 2007. Last month, the FDA gave Teva the go-ahead to launch 20 mg and 40 mg versions of generic Protonix. But since the district court has not yet held a trial on the merits of the case, Teva must decide whether to launch at risk or to wait for a favorable verdict. At this point, Teva has not begun shipment of generic Protonix.
Wyeth’s stock price has already taken a hit from the ruling. After the court decision was announced on Thursday, Wyeth’s stock fell by $1.82/share in late-day trading.
UPDATE: In a research note Monday, pharma analyst Joe Tooley of A.G. Edwards said he expects Sun Pharma to receive final FDA approval today. Additionally, he stated that if both Teva and Sun decide to launch at-risk, the branded market for Protonix could contract as much as $500 million in the remaining months of this year.
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