Teva Announces Favorable Court Ruling In Generic Hyzaar And Cozaar Litigation

Teva Pharmaceutical Industries Ltd. announced recently that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva's favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium).

Teva's Abbreviated New Drug Applications will be eligible for final approval in April 2010, when the method of use patent expires. As the first company to file the ANDAs that contained a paragraph IV certification for Hyzaar and Cozaar, and as a result of today's decision by the appellate court, Teva should be eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products. Pursuant to the appellate court's judgment, Teva's lawsuit will now be remanded to the district court for the entry of relief consistent with today's decision.

Annual sales of the brand products were approximately $1.5B in the United States based on IMS sales data.

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.

SOURCE: Teva Pharmaceutical Industries Ltd.