Mounjaro Patent Expiration

Mounjaro is a drug owned by Eli Lilly And Co. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2039. Details of Mounjaro's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9474780 GIP and GLP-1 co-agonist compounds
Jan, 2036

(11 years from now)

Active
US11357820 GIP/GLP1 agonist compositions
Jun, 2039

(14 years from now)

Active


FDA has granted several exclusivities to Mounjaro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mounjaro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Mounjaro.

Exclusivity Information

Mounjaro holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Mounjaro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 13, 2027

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US patents provide insights into the exclusivity only within the United States, but Mounjaro is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Mounjaro's family patents as well as insights into ongoing legal events on those patents.

Mounjaro's family patents

Mounjaro has patent protection in a total of 43 countries. It's US patent count contributes only to 7.8% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Mounjaro.

Family Patents

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Generic Launch

Generic Release Date:

Mounjaro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Mounjaro Generics:

There are no approved generic versions for Mounjaro as of now.





About Mounjaro

Mounjaro is a drug owned by Eli Lilly And Co. It is used for improving glycemic control in adults with type 2 diabetes mellitus. Mounjaro uses Tirzepatide as an active ingredient. Mounjaro was launched by Eli Lilly And Co in 2023.

Market Authorisation Date:

Mounjaro was approved by FDA for market use on 28 July, 2023.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Mounjaro is 28 July, 2023, its NCE-1 date is estimated to be 13 May, 2026

Active Ingredient:

Mounjaro uses Tirzepatide as the active ingredient. Check out other Drugs and Companies using Tirzepatide ingredient

Treatment:

Mounjaro is used for improving glycemic control in adults with type 2 diabetes mellitus.

Dosage:

Mounjaro is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS
5MG/0.5ML (5MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS
7.5MG/0.5ML (7.5MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS
10MG/0.5ML (10MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS
12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS
15MG/0.5ML (15MG/0.5ML) SOLUTION Prescription SUBCUTANEOUS