Wyeth announces launch of own generic version of Protonix

NEW YORK Wyeth on Tuesday announced the U.S. launch of its own generic version of Protonix (pantoprazole) in response to December’s at-risk launch of a generic version by Teva Pharmaceuticals.

“Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients,” said Bernard Poussot, president and chief executive officer for Wyeth. “We believe the Protonix compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva.”

The patent on Protonix is not set to expire until July 2010. Wyeth and Altana Pharma AG—recently acquired by Wyeth’s business partner Nycomed—sued Teva and Sun Pharmaceuticals for patent infringement based on Teva’s and Sun’s filing of applications seeking Food and Drug Administration approval to market generic versions of Protonix patent expiry.

The filing of the initial lawsuit had stayed final FDA approval of Teva’s generic until Aug. 2, 2007, and Sun’s until Sept. 8, 2007, but on Sept. 6, the U.S. District Court for the District of New Jersey denied the brand name companies’ motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to a preliminary injunction. Teva had agreed to refrain from shipping additional quantities of the drug—following its initial launch—until the end of the standstill period, which expired on Jan. 22.

The release of Wyeth’s generic—and the competition it creates—will be beneficial for both consumers and drug retailers, but Goldman Sachs’ John Heinbockel stated on Tuesday that it was especially good for retailers with associated PBMs, such as CVS’ Caremark. “Not only will this incrementally drive generic penetration higher, but with multiple competing products on the market, procurement costs should fall temporarily benefiting gross profits,” he stated.

“Medco has said that generic Protonix would add between 8 cents and 10 cents to profits in 2008. This would translate into roughly $35 million of pretax earnings,” Heinbockel continued. “We would expect Caremark to be somewhat similarly impacted. On CVS' share base, this would represent about 1.5 cents in EPS. There would also be some benefit on the retail side, as drug retailers typically make $2-$4 more in gross profits per script on generics than brands.”

Wyeth, along with its business partner Nycomed, have started distributing the generic this week through Prasco.

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