Generic Mounjaro Availability
Last updated on Jun 11, 2025.
Mounjaro is a brand name of tirzepatide, approved by the FDA in the following formulation(s):
MOUNJARO (tirzepatide - solution;subcutaneous)
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Manufacturer: ELI LILLY AND CO
Approval date: July 28, 2023
Strength(s): 2.5MG/0.5ML (2.5MG/0.5ML) [RLD], 5MG/0.5ML (5MG/0.5ML) [RLD], 7.5MG/0.5ML (7.5MG/0.5ML) [RLD], 10MG/0.5ML (10MG/0.5ML) [RLD], 12.5MG/0.5ML (12.5MG/0.5ML) [RLD], 15MG/0.5ML (15MG/0.5ML) [RLD]
Is there a generic version of Mounjaro available?
No. There is currently no therapeutically equivalent version of Mounjaro available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mounjaro. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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GIP/GLP1 agonist compositions
Patent 11,357,820
Issued: June 14, 2022
Inventor(s): Corvari Vincent John & Minie Christopher Sears & Mishra Dinesh Shyamdeo & Qian Ken Kangyi
Assignee(s): Eli Lilly and CompanyA composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
Patent expiration dates:
- June 14, 2039✓✓
- June 14, 2039
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Method of using a GIP/GLP1 co-agonist for diabetes
Patent 12,295,987
Issued: May 13, 2025
Inventor(s): Alsina-Fernandez; Jorge et al.
Assignee(s): Eli Lilly and Company (Indianapolis, IN)Provided herein are methods of treating type 2 diabetes (T2D) using a novel dosing regimen of a GIP:GLP-1 Peptide having a GIP:GLP-1 receptor agonist potency ratio that is about 2.5:1 to about 10:1 GIP to GLP-1. Also provided herein are methods of treating T2D using a novel dosing regimen of a GIP:GLP-1 Peptide having a GIP:GLP-1 receptor agonist potency ratio that is about 2.5:1 to about 5:1 GIP to GLP-1.
Patent expiration dates:
- December 30, 2041✓
- December 30, 2041✓
- December 30, 2041
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GIP and GLP-1 co-agonist compounds
Patent 9,474,780
Issued: October 25, 2016
Inventor(s): Bokvist Bengt Krister & Coskun Tamer & Cummins Robert Chadwick & Alsina-Fernandez Jorge
Assignee(s): Eli Lilly and CompanyThe present invention relates to dual incretin peptide mimetic compounds that agonize receptors for both human glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), and may be useful for treating type 2 diabetes mellitus (T2D).
Patent expiration dates:
- January 5, 2036✓✓✓
- January 5, 2036
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- May 13, 2027 - NEW CHEMICAL ENTITY
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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