Mounjaro (autoinjector) is a drug owned by Eli Lilly And Co. It is protected by 4 US drug patents filed in 2022 out of which none have expired yet. Mounjaro (Autoinjector)'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 (autoinjector)'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. | |||
| US9474780 | GIP and GLP-1 co-agonist compounds |
Jan, 2036
(11 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11357820 | GIP/GLP1 agonist compositions |
Jun, 2039
(14 years from now) | Active |
| US9402957 | Automatic injection device with delay mechanism including dual functioning biasing member |
Jun, 2031
(6 years from now) | Active |
| US8734394 | Automatic injection device with delay mechanism including dual functioning biasing member |
Feb, 2031
(6 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 (autoinjector)'s patents.
Latest Legal Activities on Mounjaro (autoinjector)'s Patents
Given below is the list of recent legal activities going on the following patents of Mounjaro (autoinjector).
| 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 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2024 | US9402957 |
| 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 |
FDA has granted several exclusivities to Mounjaro (autoinjector). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mounjaro (autoinjector), 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 (autoinjector).
Exclusivity Information
Mounjaro (autoinjector) holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Mounjaro (autoinjector)'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 (autoinjector) 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 (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.
Mounjaro (autoinjector)'s Family Patents
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Generic Launch
Generic Release Date:
Mounjaro (autoinjector)'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 (autoinjector) Generics:
There are no approved generic versions for Mounjaro (autoinjector) as of now.
Alternative Brands for Mounjaro (autoinjector)
Mounjaro (autoinjector) which is used for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise., 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 (autoinjector)
Mounjaro (Autoinjector) is a drug owned by Eli Lilly And Co. It is used for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. Mounjaro (Autoinjector) uses Tirzepatide as an active ingredient. Mounjaro (Autoinjector) was launched by Eli Lilly And Co in 2023.
Approval Date:
Mounjaro (autoinjector) 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 (autoinjector) is 28 July, 2023, its NCE-1 date is estimated to be 13 May, 2026.
Active Ingredient:
Mounjaro (autoinjector) uses Tirzepatide as the active ingredient. Check out other Drugs and Companies using Tirzepatide ingredient
Treatment:
Mounjaro (autoinjector) is used for improving glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.
Dosage:
Mounjaro (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/0.5ML (5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 7.5MG/0.5ML (7.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 15MG/0.5ML (15MG/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 |