Authorized Generics Have Arrived: Wyeth Launch's a Generic Version of its Protonix Brand

Wyeth announced yesterday that it is introducing a generic version of its blockbuster heartburn medication Protonix. The company is embroiled in nasty patent litigation with Israel-based Teva, one of the world’s largest generic drug manufacturers. The lawsuit, filed by Wyeth, claims that TEVA violated a violation of Protonix's patent which is set to expire in 2010. Teva introduced a generic version of the drug in December, which caused Protonix's sales to plummet, but then agreed to temporarily halt selling its rival product, known as pantoprazole, as the two companies engaged in settlement talks.

Protonix, one of Wyeth's top sellers, posted $1.45 billion of sales in the first nine months of 2007. Wyeth yesterday said its generic version would be distributed by Prasco Laboratories, a closely held Cincinnati company. A Teva spokeswoman declined to comment on what Wyeth's generic version means for settlement talks or whether Teva will resume sales of its own generic.

A steep drop in Protonix sales, which would be expected in the face of generic competition, would deliver yet another blow to Wyeth, which has tried and failed to win approval for some of its new medications including Pristiq for menopause symptoms and bazedoxifene for osteoporosis. Wyeth’s unprecedented move of a introducing a generic version of Protonix before patent expiry indicates how reliant the company is on sales of its blockbuster product.

If a court finds that Teva violated the Wyeth patent, Teva may have to pay triple damages awarded to the patent holder.

Until next time…

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