MOUNJARO (AUTOINJECTOR) Drug Patent Profile
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Which patents cover Mounjaro (autoinjector), and what generic alternatives are available?
Mounjaro (autoinjector) is a drug marketed by Eli Lilly And Co and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and eleven patent family members in forty-four countries.
The generic ingredient in MOUNJARO (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.
DrugPatentWatch® Generic Entry Outlook for Mounjaro (autoinjector)
Mounjaro (autoinjector) will be eligible for patent challenges on May 13, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
Indicators of Generic Entry
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Summary for MOUNJARO (AUTOINJECTOR)
| International Patents: | 111 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | MOUNJARO (AUTOINJECTOR) at DailyMed |
-patent-expirations.png "MOUNJARO (AUTOINJECTOR) drug patent expirations")
US Patents and Regulatory Information for MOUNJARO (AUTOINJECTOR)
MOUNJARO (AUTOINJECTOR) is protected by two US patents and one FDA Regulatory Exclusivity.
Patents protecting MOUNJARO (AUTOINJECTOR)
GIP/GLP1 agonist compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
GIP and GLP-1 co-agonist compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MOUNJARO IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
FDA Regulatory Exclusivity protecting MOUNJARO (AUTOINJECTOR)
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-001 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-006 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-003 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-002 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-004 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-003 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-006 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 (AUTOINJECTOR)
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly Nederland B.V. | Mounjaro | tirzepatide | EMEA/H/C/005620 Mounjaro 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 (AUTOINJECTOR)
See the table below for patents covering MOUNJARO (AUTOINJECTOR) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3242887 | COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) | ⤷ Sign Up |
| El Salvador | 2017005453 | COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1 | ⤷ Sign Up |
| Taiwan | 201636362 | GIP and GLP-1 co-agonist compounds | ⤷ Sign Up |
| Israel | 276492 | תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds) | ⤷ Sign Up |
| South Korea | 101957620 | ⤷ Sign Up | |
| Costa Rica | 20200634 | COMPOSICIONES AGONISTAS DE GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS) | ⤷ Sign Up |
| Eurasian Patent Organization | 201590037 | АВТОМАТИЧЕСКОЕ ИНЪЕКЦИОННОЕ УСТРОЙСТВО С ЗАМЕДЛИТЕЛЕМ, ВКЛЮЧАЮЩИМ СМЕЩАЮЩИЙ ЭЛЕМЕНТ С ДВОЙСТВЕННОЙ ФУНКЦИЕЙ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOUNJARO (AUTOINJECTOR)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3242887 | 122023000012 | Germany | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
| 3242887 | 301217 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919 |
| 3242887 | PA2023504 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
| 3242887 | 2023C/506 | Belgium | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919 |
| 3242887 | CA 2023 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919 |
| 3242887 | C03242887/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022 |
| 3242887 | LUC00296 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919 |
| >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. 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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