TEVA Gets FDA Nod for Uzedy Label Expansion in Bipolar I Disorder
Teva Pharmaceutical Industries Limited recently announced that the FDA has approved expanded use of its branded product, Uzedy (risperidone).The FDA approved Uzedy as once-monthly maintenance therapy for adults with bipolar I disorder. Uzedy sales surged 134% in H1 2025 to $93 million, with full-year sales expected to be around $200 million. The BD-I label expansion is expected to further strengthen Teva's branded drug portfolio.
The regulatory body has now approved Uzedy (50 mg, 75 mg and 100 mg) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of adults with bipolar I disorder (BD-I).
Uzedy extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, is already approved in the United States for the treatment of schizophrenia.
The FDA’s review supporting Uzedy’s approval for the treatment of BD-I included prior findings on the safety and efficacy of earlier risperidone formulations approved for BD-I, along with data from two pivotal phase III studies evaluating the efficacy, long-term safety and tolerability of Uzedy in patients with schizophrenia.
Year to date, shares of Teva have declined 9.1% against the industry’s 2.2% rise. The approval for the BD-I indication is likely to boost Uzedy sales further in 2025 and beyond.
Per the company, BD-I is linked to poor long-term outcomes and a significantly higher risk of death compared to the general population, mainly due to suicide and cardiovascular disease.
Teva has been witnessing continued market share growth of its newest branded drugs, including Uzedy, Austedo and Ajovy. Austedo sales rose 29% year over year in the first half of 2025 to $891 million. Teva expects Austedo annual revenues to be more than $2.5 billion by 2027 and exceed $3 billion by 2030. Ajovy sales rose 34% year over year in the first half of 2025 to $117 million.
Teva has also made decent progress with its branded pipeline, which includes olanzapine, a long-acting subcutaneous injectable for treating schizophrenia and duvakitug, its anti-TL1A therapy for inflammatory bowel diseases, ulcerative colitis (UC) and Crohn’s disease (CD).
Teva has partnered with Sanofi (SNY Quick QuoteSNY - Free Report) for duvakitug to maximize the value of the asset. Teva and Sanofi will equally share the development costs globally. Sanofi plans to advance duvakitug into phase III studies for both UC and CD later in the fourth quarter of 2025. Teva expects to file a new drug application to seek approval for olanzapine later in the fourth quarter of 2025.
Teva anticipates generating more than $5 billion in revenues from its branded products by 2030.
