FDA Approves Expanded Use for Teva's Uzedy in Bipolar I Disorder, Bolstering Growth Strategy
Teva's Uzedy Receives FDA Expansion for Bipolar I Disorder
U.S. regulatory authorities have granted Teva Pharmaceutical Industries Limited (NYSE: TEVA) an expanded approval for its long-acting injectable drug, Uzedy (risperidone), to include the maintenance treatment of adults with bipolar I disorder (BD-I). This decision, announced in October 2025, is anticipated to significantly contribute to Teva's branded product sales growth and strategic transformation.
The Event in Detail: Uzedy's Expanded Indication and Financial Impact
The U.S. Food and Drug Administration (FDA) approved Uzedy (50 mg, 75 mg, and 100 mg) for once-monthly use as monotherapy or adjunctive therapy for BD-I. This broadens its application beyond its initial approval for schizophrenia. The formulation leverages Medincell's SteadyTeq™/BEPO® technology, which ensures controlled drug release within 6–24 hours post-injection, eliminating the need for post-injection monitoring. This subcutaneous and once-monthly dosing regimen is designed to enhance medication adherence, a critical factor for BD-I patients. Financially, Uzedy demonstrated robust performance, generating $117 million in revenue in 2024, with Q4 sales contributing $43 million. Following strong Q1 and Q2 2025 sales of $39 million and $54 million, respectively, Teva has raised its 2025 revenue outlook for Uzedy to between $190 million and $200 million. As the technology licensor, Medincell is eligible for up to $105 million in commercial milestone payments and mid- to high-single-digit royalties on sales.
Analysis of Market Reaction: A Catalyst for Teva's Growth Strategy
This FDA approval serves as a significant validation of Teva's "Pivot to Growth" strategy, underscoring its commitment to transition from a generic drug manufacturer to a leader in specialty therapeutics. The expanded indication for Uzedy is a cornerstone of the company's ambitious goal to generate more than $5 billion in revenues from its innovative branded products by 2030. This strategic move is poised to enhance market access by addressing payer priorities through the potential reduction of hospitalizations and improved patient outcomes. The broader market sentiment surrounding such pipeline successes has been bullish, with Teva's stock experiencing gains on recent regulatory and product developments, for instance, a 1.85% rise on September 8, 2025, on increased trading volume.
Broader Context & Implications: Expanding Market Share in Psychiatric Therapeutics
Uzedy's continued success is integral to Teva's strategic transformation, complementing other key branded growth drivers such as Austedo and Ajovy. Austedo sales surged 29% year-over-year in the first half of 2025, reaching $891 million, with projections for annual revenues to exceed $2.5 billion by 2027 and $3 billion by 2030. Ajovy sales advanced 34% year-over-year in the same period to $117 million. The global bipolar I disorder treatment market, now further penetrated by Uzedy, is projected to reach $15.67 billion by 2034, exhibiting a compound annual growth rate (CAGR) of 5.43%. The U.S. BD-I treatment market alone is estimated to reach $3.5 billion by 2034. Long-acting injectables (LAIs) have seen significant adoption growth of 45% over the past five years, driven by adherence benefits, positioning Uzedy's subcutaneous delivery and flexible dosing advantageously within a market dominated by Second-Generation Antipsychotics (SGAs).
Looking Ahead: Pipeline Development and Future Revenue Targets
The Uzedy expansion significantly strengthens Teva's neuroscience portfolio. Analysts project that Teva's combined schizophrenia and BD-I LAI portfolio could reach $1.5 billion to $2 billion in peak sales by 2030. Further reinforcing its psychiatric drug market presence, Teva plans to file a New Drug Application (NDA) for a long-acting injectable olanzapine formulation (TEV-749/mdc-TJK) in Q4 2025. This investigational product is also projected to contribute significantly, with analyst estimates suggesting potential sales of $1.5 billion to $2 billion by 2030. These pipeline developments and strategic expansions are critical for Teva to achieve its ambitious $5 billion innovative medicine sales target by 2030 and to continue its evolution into a leading biopharmaceutical company.
