Drug facts
BrandMounjaro (Tirzepatide)
No generic tirzepatide is approved; the latest Mounjaro patent or exclusivity in the Orange Book runs to 12/30/2041.
Mounjaro was first approved by the FDA on 05/13/2022 under NDA 215866; the application holder is Eli Lilly and Co.
The latest NADAC for MOUNJARO 5 MG/0.5 ML PEN is $538.70 per mL (as of 10/28/2026).
Holder Eli Lilly and CoApplication NDA 215866Approved 05/13/2022
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
5,539days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/13/2022
Exclusivity ends12/19/2028
Last patent12/30/2041
2023202620292032203520382041
- Latest patent
- 12/30/2041Mounjaro Orange Book
- Exclusivity
- 12/19/2028Mounjaro Orange Book
02Competition
- Generics
- No generic approved Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Mounjaro profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $538.70 per mLMOUNJARO 5 MG/0.5 ML PEN, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Eli Lilly and Co Orange Book
- Application
- NDA 215866 Orange Book
- First approved
- 05/13/2022 Orange Book
- Dosage forms
- solution
- Routes
- subcutaneous
- Other brand names
- Zepbound
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.