OTP EXLCUSIVE: Mounjaro and Zepbound MULTI-USE Vials Coming Soon!
- Dave Knapp
- 5 days ago
- 2 min read
Originally posted on obesity.news on January 15th, 2026
Eli Lilly has secured FDA approval for multi use vials of both Zepbound and Mounjaro, according to newly updated package inserts reviewed by On The Pen. The approvals mark the first time Mounjaro has been cleared for vial based distribution in the United States and represent a notable shift in how Lilly may supply its blockbuster tirzepatide franchise.
The changes appear in prescribing information revised in January 2026, without accompanying public announcement from the company. Both labels now list FDA approved multi use vial presentations alongside the existing single dose pens and and single-dose vials.
For Zepbound, the FDA approved multi use vials are designed to deliver four weekly doses per vial. The smallest vial cont
ains 10 mg of tirzepatide in 2.4 mL, intended for four 2.5 mg doses administered at 0.6 mL each. Larger vials scale accordingly, with a 20 mg vial delivering four 5 mg doses, a 30 mg vial delivering four 7.5 mg doses, a 40 mg vial delivering four 10 mg doses, a 50 mg vial delivering four 12.5 mg doses, and a 60 mg vial delivering four 15 mg doses.
While the labels do not specify pricing or distribution channels, industry observers expect the vials to be positioned for the cash pay market initially, offering an alternative to the single dose vial system that has dominated Lilly’s commercial rollout.
This revelation comes as somewhat of a surprise, as previous announcements had pointed to the potential addition of Zepbound multi-use pens for the cash pay market. It is unclear if this approval marks a pivot away from the previous announcement, or if the new vials will be offered in addition to the pens. The multi-dose pens have yet to gain U.S. approval.
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Beyond access and pricing implications, the regulatory move may carry legal significance. Multi use vials allow prescribers to draw variable doses from an FDA approved branded product, an argument compounders have leaned on in recent years to justify custom dosing of tirzepatide once shortages ended. By bringing branded multi use vials to market, Lilly strengthens its position that prescribers no longer need compounded alternatives to achieve dosing flexibility.
That shift could bolster Lilly’s hand as it continues to press regulators and courts to curtail compounded tirzepatide. The presence of FDA approved, multi use branded vials potentially undercuts one of the more durable justifications compounders have relied upon.
Timing remains uncertain. The approvals are already finalized, but early signals from within Lilly suggest commercial availability may not arrive until spring. If that timeline holds, the rollout would coincide with a broader recalibration of the GLP-1 market, as manufacturers, pharmacies, and payers brace for the next phase of access battles.
For now, the key takeaway is simple. The FDA paperwork is done. The vials are real. And Lilly has quietly expanded the battlefield.
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