MOUNJARO KWIKPEN Drug Patent Profile
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Which patents cover Mounjaro Kwikpen, and when can generic versions of Mounjaro Kwikpen launch?
Mounjaro Kwikpen is a drug marketed by Eli Lilly And Co and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-two patent family members in forty-six countries.
The generic ingredient in MOUNJARO KWIKPEN is tirzepatide. Two suppliers are listed for this compound. Additional details are available on the tirzepatide profile page.
DrugPatentWatch® Generic Entry Outlook for Mounjaro Kwikpen
Mounjaro Kwikpen was eligible for patent challenges on May 13, 2026.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
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Summary for MOUNJARO KWIKPEN
| International Patents: | 152 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| DailyMed Link: | MOUNJARO KWIKPEN at DailyMed |
Paragraph IV (Patent) Challenges for MOUNJARO KWIKPEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MOUNJARO KWIKPEN | Subcutaneous Solution | tirzepatide | 12.5 mg/0.5 mL | 215866 | 1 | 2026-05-13 |
US Patents and Regulatory Information for MOUNJARO KWIKPEN
MOUNJARO KWIKPEN is protected by twelve US patents and two FDA Regulatory Exclusivities.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-024 | Jan 20, 2026 | RX | Yes | Yes | 9,474,780 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-021 | Jan 20, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-023 | Jan 20, 2026 | RX | Yes | Yes | 9,474,780 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-022 | Jan 20, 2026 | RX | Yes | Yes | 12,295,987 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-022 | Jan 20, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-020 | Jan 20, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eli Lilly And Co | MOUNJARO KWIKPEN | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-021 | Jan 20, 2026 | RX | Yes | Yes | 9,474,780 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for MOUNJARO KWIKPEN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly Nederland B.V. | Mounjaro | tirzepatide | EMEA/H/C/005620Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. | Authorised | no | no | no | 2022-09-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MOUNJARO KWIKPEN
See the table below for patents covering MOUNJARO KWIKPEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 115542 | ⤷ Start Trial | |
| Australia | 2019289110 | ⤷ Start Trial | |
| Australia | 2022279524 | ⤷ Start Trial | |
| Australia | 2024266715 | ⤷ Start Trial | |
| Brazil | 112020023452 | ⤷ Start Trial | |
| Canada | 3103469 | ⤷ Start Trial | |
| Chile | 2020003359 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOUNJARO KWIKPEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3242887 | CA 2023 00005 | Denmark | ⤷ Start Trial | PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919 |
| 3242887 | 301217 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919 |
| 3242887 | PA2023504 | Lithuania | ⤷ Start Trial | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
| 3242887 | 2023C/506 | Belgium | ⤷ Start Trial | PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919 |
| 3242887 | LUC00296 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919 |
| 3242887 | 122023000012 | Germany | ⤷ Start Trial | PRODUCT NAME: TIRZEPATID UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
| 3242887 | C03242887/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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