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. Mounjaro's patents will be open to challenges from 13 May, 2026. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11357820 | GIP/GLP1 agonist compositions |
Jun, 2039
(14 years from now) | Active |
| US9474780 | GIP and GLP-1 co-agonist compounds |
Jan, 2036
(10 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Mounjaro's patents.
Latest Legal Activities on Mounjaro's Patents
Given below is the list of recent legal activities going on the following patents of Mounjaro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2024 | US9474780 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9474780 |
| Second letter to regulating agency to determine regulatory review period | 23 Oct, 2023 | US9474780 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US9474780 |
| Post Issue Communication - Certificate of Correction | 20 Oct, 2022 | US11357820 |
| Initial letter Re: PTE Application to regulating agency | 29 Aug, 2022 | US9474780 |
| Sequence Moved to Public Database | 14 Jun, 2022 | US11357820 |
| Recordation of Patent Grant Mailed Critical | 14 Jun, 2022 | US11357820 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Jun, 2022 | US11357820 |
| Email Notification Critical | 27 May, 2022 | US11357820 |
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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Mounjaro:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Mounjaro(Tirzepatide) has 8 clinical trials that have been verified in 2024. Out of these 8, 1 trial is in PHASE4.
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.
Alternative Brands for Mounjaro
Mounjaro which is used for improving glycemic control in adults with type 2 diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Tirzepatide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Eli Lilly And Co |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tirzepatide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Eli Lilly And Co |
|
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.
Approval Date:
Mounjaro was approved by FDA for market use on 28 July, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |
|---|---|---|---|
| 10MG/0.5ML (10MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 15MG/0.5ML (15MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 5MG/0.5ML (5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 7.5MG/0.5ML (7.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |