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[1] GLP-1/GIP agents such as tirzepatide are not currently listed as disqualifying by major US blood organizations

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Viatris lawsuit is the one to watch 20312033: Most analysts' baseline forecast for final FDA approval and US market launch, assuming patents run their course 20332036: More conservative estimates accounting for remaining IP layers What could change this timeline: Further successful patent challenges by generic manufacturers Congressional or executive action to accelerate generic biologics access Expanded FDA streamlining of the biosimilar approval pathway For now, the cost relief available globally in 2026 will not reach US patients through the generic or biosimilar route