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U.S. Consumers May Have Paid Too Much For Procardia XL

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Case ID: 2746 | Drugs / Medical | 07/19/2004

A class action has been filed against drug manufacturers Pfizer, Inc. and Mylan Laboratories, Inc. on behalf of U.S. citizens who paid out-of-pocket expenses between February 28, 2000, and February 6, 2001, for the prescription drug Procardia XL, alleging a conspiracy between the two companies to prevent the marketing of a generic version of Procardia XL. The action seeks disgorgement of profits wrongfully generated by the sale of Procardial XL, reimbursement for the class and declaratory relief.

Procardia is a "once a day" time-release medication that contains Nifedipine and is used to combat hyptertension and angina. One of Pfizer's best selling drugs, Procardia has been very profitable for the pharmaceutical giant, with sales in 1991 of $521 million. Mylan, one of the nation's largest and most successful producers of generic drugs, developed a generic version of the most popular dosage of Nifedipine, 30 milligrams.

On April 7, 1997, Mylan applied to the FDA for initial approval of the company's generic version of Procardia XL. Mylan certified to the FDA that either its version of the drug did not infringe upon Pfizer's patent or Pfizer's patent was unenforceable. As the first company to bring this generic to the market, Mylan was allowed a 180-day period in which it would have the exclusive right to sell a generic 30 mg version of Procardia XL. This 180-day period was to begin either when Mylan began to sell the drug or the FDA ruled that Mylan's generic version did not infringe upon Pfizer's patent.

In July 1997, Pfizer filed suit against Mylan for patent infringement. The suit was dismissed in 2000 after the two companies entered into an agreement whereby Mylan would purchase Procardia XL from Pfizer and sell it under Mylan's own name, instead of selling the generic drug Mylan developed. This agreement had the effect of freezing the market for a generic version of Procardia XL, since Mylan was afforded special status by the FDA but was not marketing its own version.

On February 6, 2001, the FDA decided that Mylan was no longer entitled to special status and approved an application by Biovail Corporation for its generic version of Procardia XL. Finally, consumers were able to purchase a true generic version of Procardia instead of a version that was typically marketed at a 5% discount by Mylan. However, due to Pfizer's and Mylan's actions, consumers were forced for over a year to pay artificially controlled prices for Procardia XL.


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