Teva Raises UZEDY Revenue Outlook to $190-200M as Medincell's Olanzapine Injectable Advances Toward FDA Filing
Key Insights
Teva Pharmaceuticals increased UZEDY's 2025 revenue outlook from approximately $160 million to $190-200 million, driven by Q2 2025 sales of $54 million representing a 2.2x increase year-over-year.
Medincell (search)'s olanzapine long-acting injectable completed pivotal Phase 3 trials in January 2025 with positive efficacy results and no post-injection delirium/sedation syndrome (PDSS).
The olanzapine NDA submission is planned for Q4 2025, targeting the most prescribed antipsychotic for schizophrenia (search) in the U.S. market.
Teva Pharmaceuticals has significantly raised its 2025 revenue outlook for UZEDY (risperidone) from approximately $160 million to $190-200 million, reflecting accelerating commercial momentum for Medincell (search)'s long-acting injectable antipsychotic. The updated forecast follows strong Q2 2025 performance, with sales reaching $54 million representing a 2.2x increase compared to Q2 2024.
UZEDY Commercial Performance Exceeds Expectations
UZEDY, a 1-month and 2-month subcutaneous risperidone formulation for schizophrenia (search), has demonstrated robust market uptake since its U.S. commercialization began in May 2023. First-half 2025 sales totaled $93 million, marking a 2.3x increase compared to H1 2024, while full-year 2024 sales reached $117 million.
The treatment utilizes Medincell (search)'s proprietary BEPO (search) technology, licensed to Teva under the SteadyTeq trademark, which controls drug delivery at therapeutic levels for extended periods through subcutaneous injection. Medincell receives mid- to high-single digit royalties on all UZEDY sales and remains eligible for $105 million in commercial milestones.
Olanzapine Injectable Advances Toward Regulatory Filing
Medincell (search)'s second major program, a 1-month subcutaneous olanzapine long-acting injectable (TEV-749/mdc-TJK), has completed pivotal Phase 3 trials with positive efficacy results and notably achieved no post-injection delirium/sedation syndrome (PDSS). The compound targets olanzapine, identified as the most prescribed antipsychotic for schizophrenia (search) in the United States.
PDSS represents a significant barrier to existing olanzapine long-acting injectable formulations, occurring when medication unintentionally enters the bloodstream too rapidly, causing sudden sedation, confusion, and potentially serious respiratory complications. The requirement for close post-injection monitoring limits treatment convenience and accessibility for current olanzapine LAI options.
Regulatory Timeline and Commercial Potential
Full maintenance efficacy and safety data for the olanzapine injectable are planned for presentation in Q3 2025, with NDA submission targeted for Q4 2025. Following NDA submission, the FDA typically requires approximately 2 months to determine acceptance for review, followed by an additional 8 months for standard review before potential approval.
Medincell (search) is eligible for $7 million in development milestones for the olanzapine program. Upon approval, the company will receive mid- to high-single digit royalties on all sales and becomes eligible for an additional $105 million in commercial milestones.
Technology Platform and Strategic Positioning
Medincell (search)'s BEPO (search) technology platform enables controlled drug delivery over days, weeks, or months through subcutaneous or local injection of entirely bioresorbable deposits measuring just a few millimeters. The Montpellier-based company operates as a clinical- and commercial-stage biopharmaceutical licensing company, collaborating with leading pharmaceutical companies to develop long-acting injectable treatments across multiple therapeutic areas.
The company currently employs more than 140 people representing over 25 nationalities and focuses on improving treatment compliance, medication effectiveness and accessibility while reducing environmental impact through its innovative delivery platform.