FDA Proposes Semaglutide Compounding Ban as Sales Hit $59B
U.S. prescription spending rose nearly 13% to $915 billion in 2025 with GLP-1 drugs driving a nationwide surge; Novo Nordisk's semaglutide generated wholesale purchases of over $59 billion last year. The FDA proposed excluding semaglutide from bulk compounding, potentially blocking unauthorized copies and protecting Wegovy and Ozempic sales.
1. U.S. Prescription Spending Surge
U.S. spending on prescription drugs climbed 13% to $915 billion in 2025, driven largely by GLP-1 weight-loss and diabetes treatments, and is projected to exceed $1 trillion in 2026.
2. Semaglutide’s $59B Wholesale Purchases
Novo Nordisk’s semaglutide products Wegovy and Ozempic ranked second nationally with wholesale purchases surpassing $59 billion in 2025, trailing only Eli Lilly’s tirzepatide at $63 billion.
3. FDA Proposes Compounding Exclusion
The FDA proposed removing semaglutide and other GLP-1 drugs from the 503B bulk compounding list, aiming to curb unauthorized copies, bolster branded supply chains, and protect Wegovy and Ozempic sales pending a final decision by June 29.