Teva's Generic Zyprexa, Norvasc Get Tentative Approvals From FDA
Teva Pharmaceutical has received tentative approval from the FDA to launch generic versions of two blockbuster drugs -- Eli Lilly's antidepressant Zyprexa and Pfizer's blood pressure medication Norvasc.
The Israel-based generic firm's launch of olanzapine, the active ingredient in Zyprexa, is dependent on the resolution of its ongoing patent litigation with Lilly and the expiration of any applicable exclusivity period held by another generic firm, Teva said. Teva, Ivax and Dr. Reddy's have all sued Lilly over its Zyprexa patent, which is currently set to expire in 2011.
Teva approval is for olanzapine tablets in 2.5-, 5-, 7.5-, 10-, 15- and 20-mg strengths. Zyprexa was the fifth best-selling drug on the market in 2004, generating worldwide sales of $4.8 billion, according to IMS Health data. Teva has also received tentative approval to launch a generic version of Pfizer's Norvasc (amlodipine besylate). The approval covers amlodipine besylate tablets in 2.5-, 5- and 10-mg strengths.
Teva anticipates that the FDA will grant final approval to its abbreviated new drug application when Pfizer's patent protection expires Sept. 25, 2007. Norvasc is Pfizer's second-highest-selling drug, generating roughly $4.5 billion in revenues in 2004.