FDA approves Sun's generic Protonix

MUMBAI, India Sun Pharma has received an approval from the Food and Drug Administration to launch a generic version of the Wyeth and Altana Pharma AG heartburn and anti-ulcer drug Protonix.

Pharma and Teva now share a 180-day exclusive marketing right to launch the drug, which saw annual sales exceed $2 billion in the U.S. market.  Wyeth and Atlana Pharma AG have sued the two companies over patent infringement based on their applications to market a generic for Protonix before the patent expired on July 19, 2010.

A week ago, the New Jersey District Court had dismissed a petition filed by Wyeth and Altana AG for a temporary injunction to prevent launch of the generic version of Protonix (pantoprazole delayed-release tablets).