Eli Lilly Stocks $1.5 Billion Orforglipron Ahead of April FDA Decision
By February 2026, Eli Lilly had capitalized $1.5 billion in pre-launch inventory for orforglipron, including $550 million built by February 2025. The FDA is expected to decide on the oral GLP-1RA in April 2026 under a priority review voucher as Lilly aims to avoid previous injectable shortages.
1. Inventory Build-Up
By February 2026, Lilly had capitalized $1.5 billion in pre-launch inventory for orforglipron, including $550 million built by February 2025 to ensure immediate supply upon launch.
2. FDA Approval Timeline
Orforglipron is under FDA review with a decision expected in April 2026, expedited through a Commissioner’s National Priority Review Voucher that shortens the standard review period.
3. Lessons from Injectable Shortages
In 2022, unprecedented demand for injectable GLP-1RAs led to shortages of tirzepatide products Zepbound and Mounjaro, driving patients to compounding pharmacies and eroding Lilly’s revenue until supply normalized in late 2024.
4. Market Outlook and Competition
If approved, orforglipron is projected to generate $13 billion in global sales by 2031, positioning Lilly to challenge Novo Nordisk’s first‐mover advantage established by oral Wegovy in January 2026.