Drug: Cozaar (losartan potassium)/Hyzaar (hydrochlorothiazide; losartan potassium)
Patent Expiration: Aug. 11, 2009/Pediatric Exclusivity through Feb. 11
Scoop: Patents covering Merck's hypertension treatments Cozaar/Hyzaar expire this year. Global sales of the franchise were $861 million for the third quarter of 2009, representing a 3 percent decrease compared with the same period 2008. Merck will lose exclusivity in the U.S. and major European markets during the first half of the year. The blood pressure franchise Zydus, Lek Pharma and Aurobindo have tentative approval for their generic versions of Cozaar. The ’069 patent has pediatric exclusivity until Feb. 11. But the pediatric exclusivity on another patent prevents the FDA from approving a generic-drug maker's ANDA until April 6.