Mounjaro Kwikpen is a drug owned by Eli Lilly And Co. It is protected by 3 US drug patents filed in 2026 out of which none have expired yet. Mounjaro Kwikpen'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 Dec 30, 2041. Details of Mounjaro Kwikpen'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
(9 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). | |||
| US12295987 | Method of using a GIP/GLP1 co-agonist for diabetes |
Dec, 2041
(15 years from now) | Active |
| US12343382 | Methods Of Using A Gip/Glp1 Co-Agonist For Therapy |
Jul, 2039
(13 years from now) | Active |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Mounjaro Kwikpen and ongoing
litigations to
help you estimate the early arrival of Mounjaro Kwikpen generic.
Mounjaro Kwikpen's Litigations
Mounjaro Kwikpen been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 22, 2025, against patent number US9474780. The petitioner Empower Clinic Services, LLC. (d/b/a Empower Pharmacy), challenged the validity of this patent, with Eli Lilly & Co. as the respondent. Click below to track the latest information on how companies are challenging Mounjaro Kwikpen's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9474780 | August, 2025 |
Discretionary Denial
(11 Dec, 2025) | Eli Lilly & Co. | BPI Labs, LLC et al. |
| US9474780 | May, 2025 |
Discretionary Denial
(10 Oct, 2025) | Eli Lilly & Co. | Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) |
US patents provide insights into the exclusivity only within the United States, but
Mounjaro Kwikpen 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 Kwikpen's family patents as well as insights into
ongoing legal events
on those patents.
Mounjaro Kwikpen's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Mounjaro Kwikpen:
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 Kwikpen(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 Kwikpen's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 30, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mounjaro Kwikpen Generics:
There are no approved generic versions for Mounjaro Kwikpen as of now.
Alternative Brands for Mounjaro Kwikpen
There are several other brand drugs in the same treatment category and using the same active ingredient (Tirzepatide) as Mounjaro Kwikpen. 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 Kwikpen
Mounjaro Kwikpen is a drug owned by Eli Lilly And Co. Mounjaro Kwikpen uses Tirzepatide as an active ingredient. Mounjaro Kwikpen was launched by Eli Lilly in 2023.
Approval Date:
Mounjaro Kwikpen 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 Kwikpen is 28 July, 2023, its NCE-1 date is estimated to be 13 May, 2026.
Active Ingredient:
Mounjaro Kwikpen uses Tirzepatide as the active ingredient. Check out other Drugs and Companies using Tirzepatide ingredient
Dosage:
Mounjaro Kwikpen is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/2.4ML (20.8MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 30MG/2.4ML (12.5MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 20MG/2.4ML (8.33MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 40MG/2.4ML (16.7MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 10MG/2.4ML (4.17MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |