Eli Lilly has reported holding $1.5 billion of pre-launch inventory for its investigational oral weight-loss medication, orforglipron, in a filing made public on Thursday. The inventory figure comes as the drug is set for an expected regulatory decision by the U.S. Food and Drug Administration in April.
By comparison, Lilly disclosed nearly $550 million in pre-launch stock for the same compound last year. The company has indicated it plans to have adequate supply to introduce the medicine in multiple countries almost simultaneously if U.S. approval is granted.
Orforglipron has been granted a fast-track review voucher by the FDA, a designation that could accelerate the review timeline to as little as one to two months. That contrasts with the more typical period of 10 to 12 months that most new medicines experience during review.
Separately, Danish competitor Novo Nordisk earlier this month launched a once-daily oral weight-loss pill in the United States. According to IQVIA data shared by an analyst, prescriptions for that product exceeded 26,000 in the second full week after launch.
Industry practice commonly sees drugmakers record such pre-approval inventories, often listed as assets in financial statements, to reflect the amount of drug product manufactured in anticipation of regulatory clearance. In Lilly’s case, the increase from roughly $550 million to $1.5 billion signifies a substantial buildup of finished product ahead of the agency ecision.
Context and process notes
The filing makes clear the inventory is tied specifically to the pre-launch phase for orforglipron. The FDA’s fast-track voucher attached to the program establishes a potential for an expedited review window of one to two months, though the filing does not alter the scheduled April decision date communicated previously.
The company lso stated plans to supply multiple markets nearly simultaneously if approval is achieved, reflecting logistical preparation for a broad launch but dependent on the regulatory outcome.