Barr challenging patents protecting Prozac Weekly

By Lisa Kerner

Erie, Pa., May 11 - Barr Pharmaceuticals, Inc. its subsidiary, Barr Laboratories, Inc. and Eli Lilly & Co. continue to battle over Lilly's patent protecting Prozac Weekly (Fluoxetine Hydrochloride) Capsules, USP 90 mg from generic competition.

Prozac Weekly Capsules, USP 90 mg, for the treatment of manic depressive disorder, has current annual sales of approximately $40 million, based on IMS sales data for the 12 months ended March 2006.

Barr said it was the first to file an Abbreviated New Drug Application with the Food & Drug Administration for the 90 mg capsule product in September 2001, according to a company news release.

The company notified Lilly of its ANDA filing, which contained a Paragraph IV certification to the patents listed in the Orange Book for this product.

In March 2006, Lilly obtained a reissue patent (RE39,030) and listed it in the Orange Book.

Barr then amended its ANDA to include a Paragraph IV certification to that reissued patent.

In May, Lilly filed suit against Barr on the reissue patent in the U.S. District Court, Southern District of Indiana, to prevent Barr from proceeding with the commercialization of this product.

Barr Laboratories, Inc. develops, manufactures and markets generic and proprietary pharmaceuticals.

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