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The 8-year regulatory data exclusivity window expired on January 4, 2026, and a secondary injectable-formulation patent expired in March 2026

Medical necessity typically requires documented obesity (BMI 30) plus at least one weight-related comorbidity such as type 2 diabetes, hypertension, sleep apnea, nonalcoholic fatty liver disease, or cardiovascular disease

When medication is expired or degraded, these genetic insights lose their predictive value

Mounjaro, a prescription medication containing tirzepatide, is specifically approved by the FDA for the treatment of type 2 diabetes in adults

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