Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Mar 2 2010

Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today 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 $1.5 billion in the United States based on IMS sales data.