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The Lipitor Wars: Who Gets a Piece of a $7 Billion Drug?

This article was originally published in RPM Report

Executive Summary

The world’s best-selling prescription drug is about to lose patent protection, presenting generic drug companies with their biggest marketing opportunity ever. But potential fraud by first-filer Ranbaxy is complicating the generic landscape for Pfizer’s Lipitor. The stakes are high: How FDA resolves the Ranbaxy debacle will not only determine the winners of the Lipitor battle, but could drive big changes to the generic drug law.

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One year after the biggest generic drug launch in history, Ranbaxy is halting production of atorvastatin after a manufacturing quality glitch. FDA should be grateful this didn’t happen in the first six months – but may also want to start preparing for possible investigations if the new Energy & Commerce/Oversight chairman decides to press a point.

The End of an Era: Lipitor, Blockbuster Drugs and the Waxman/Hatch Model

Pfizer’s Lipitor goes generic—albeit with some decidedly unusual wrinkles. The biggest generic launch in history is a good moment to take stock of the transition away from the blockbuster model. The reaction to the milestone suggests that the industry’s critics may be having a harder time letting go of the old model than industry is.

The War on Generics - Part II

Teva says it isn't worried about the more aggressive pricing strategies used by brand companies to blunt blockbuster generic launches. What if the world's largest generic company is wrong? Part II of this two-part series looks at the future of the generic drug industry.

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