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Published on 8/2/2006 in the Prospect News Biotech Daily.

Pfizer, Ranbaxy: both sides win one part of patent lawsuit for atorvastatin

By Lisa Kerner

Charlotte, N.C., Aug. 2 - Pfizer Inc. said a panel of the Court of Appeals for the Federal Circuit has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in Lipitor, maintaining patent protection for Lipitor in the United States until March 2010.

The ruling was made as a result of a lawsuit brought by Pfizer against the generic manufacturer Ranbaxy Ltd., according to a company news release.

In addition, the Appeals Court ruled that a second patent (U.S. 5,273,995) at issue in the lawsuit covering the calcium salt of atorvastatin is invalid on technical grounds.

As a result, Ranbaxy said it could bring the launch date of its product to March 2010 from June 2011, pending the appellate process and Food and Drug Administration authorization.

Atorvastatin is the largest-selling drug in the world with estimated annual U.S. sales of $8.5 billion, according to Ranbaxy.

Ranbaxy is an international pharmaceutical company based in Haryana, India.

Pfizer is a New York City-based pharmaceutical company.


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