BSE-listed Sun Pharmaceutical Industries got a reprieve from a US court as Pfizer-controlled Wyeth’s

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complaint on Protonix, an anti-ulcer drug, was thrown out.

The US district court for the eastern district of Michigan (Southern Division) has dismissed a complaint where Wyeth alleged that Sun and its US unit, Caraco (marketing partner), are selling generic Protonix tablets that contain a different active ingredient than required.

Sun Pharma started selling the generic version of the drug in 40 mg strength from January 2008, as a part of its at-risk launch since its patent litigation with Wyeth was still pending. Patent experts said the fresh complaint was an attempt by Wyeth to stop Sun Pharma from selling the generic version of its drug. Protonix has over $2 billion in sales a year.

Protonix, the innovator drug, contains an active ingredient known as pantoprazole sodium. Wyeth alleged in its complaint that Sun and Caraco are actually selling tablets containing a different polymorphic form of pantoprazole sodium: pantoprazole sodium monohydrate.

This, it argued, was actually a literally false statement regarding the active ingredient of the generic pharmaceutical product, in violation of the Lanham Act as well as in violation of the Michigan Consumer Protection Act. The drug sold by Sun was in fact approved by Food and Drug Administration (FDA) as the generic equivalent of Protonix.

On March 2, the US court had dismissed the complaint filed by Wyeth and granted a motion to dismiss filed by Sun Pharmaceutical Industries and Caraco Pharmaceutical Laboratories. It had asked Wyeth to check with FDA through an investigation and then come to court based on the outcome of the investigation. A copy of the judgement is with Financial Chronicle.

In an e-mailed reply, a Sun spokesperson said: “The present generic Protonix is being sold and is likely to be continued.” At present, the generic Protonix market in the US has three competitors: Teva, Sun and also an authorised generic by Wyeth itself.