says a federal court judge has ruled against its patent challenge to the hypertension drug Norvasc, which is
Mylan said Tuesday it would appeal the verdict immediately. The company didn't provide details of the ruling, but it said the decision wouldn't affect its guidance for the fiscal year ending March 31. Mylan expects earnings per share of $1.50 to $1.55, excluding items. Generic Norvasc "was never factored" into the guidance, Mylan said.
Norvasc produced $4.9 billion in sales for Pfizer last year, second only to cholesterol-fighter Lipitor's $12.9 billion. In the U.S., Norvasc's sales grew by 13% to $2.5 billion, but sales fell 5% to $2.4 billion in foreign markets.
The court victory gives Pfizer some extra time to extract sales and profit from a drug that loses U.S. patent protection in September.
The companies have been fighting each other for five years with Mylan trying to persuade the court that a Norvasc patent was invalid or unenforceable. Pfizer also won patent Norvasc patent challenges against two other generic-drug companies last year. Both rulings are being appealed.
Mylan received approval from the Food and Drug Administration in October 2005 to sell three dosage strengths of generic Norvasc. Mylan would gain 180 days of marketing exclusivity under a federal law that rewards companies for being the first filers of generic-drug applications. The exclusivity starts when a brand-name drug goes off patent.
The impact on the companies' stock prices was hard to determine given the overall market turmoil. Mylan's stock was off 43 cents, or 2%, to $21.41 on volume that was more than double the daily average. Pfizer fell 70 cents, to 2.7%, to $25.14.