TEVA Gets FDA Nod for Uzedy Label Expansion in Bipolar I Disorder

Core Insights - Teva Pharmaceutical Industries Limited (TEVA) has received FDA approval for the expanded use of its product Uzedy (risperidone) for the treatment of bipolar I disorder (BD-I) [1][8] - Uzedy is now approved as a once-monthly extended-release injectable suspension for adults with BD-I, either as monotherapy or in conjunction with lithium or valproate [1][8] - The approval is expected to significantly boost Uzedy's sales, which have already seen a 134% year-over-year increase in the first half of 2025 [6][8] Sales Performance - Uzedy's sales reached $93 million in the first half of 2025, with full-year sales projected to be between $190 million and $200 million [6][8] - The approval for BD-I is anticipated to further enhance Uzedy's sales trajectory in 2025 and beyond [6][8] Market Position and Growth - Teva has experienced market share growth for its newer branded drugs, including Uzedy, Austedo, and Ajovy [9] - Austedo's sales increased by 29% year-over-year in the first half of 2025, totaling $891 million, with expectations of exceeding $2.5 billion in annual revenues by 2027 [9][11] - Ajovy's sales rose by 34% year-over-year in the same period, reaching $117 million [9] Pipeline Developments - Teva is advancing its branded pipeline, which includes olanzapine for schizophrenia and duvakitug for inflammatory bowel diseases [10][11] - Teva has partnered with Sanofi for the development of duvakitug, with plans to enter phase III studies for ulcerative colitis and Crohn's disease in late 2025 [11] - A new drug application for olanzapine is expected to be filed in the fourth quarter of 2025 [11] Revenue Projections - Teva anticipates generating over $5 billion in revenues from its branded products by 2030 [11]