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 ten 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
Summary for MOUNJARO (AUTOINJECTOR)
International Patents: | 110 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
DailyMed Link: | MOUNJARO (AUTOINJECTOR) at DailyMed |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
GIP and GLP-1 co-agonist compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-006 | May 13, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-003 | May 13, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-002 | May 13, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-004 | May 13, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 (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 |
---|---|---|---|
Slovenia | 3242887 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2019245893 | ⤷ Try a Trial | |
Japan | 6545766 | ⤷ Try a Trial | |
Morocco | 41315 | COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1 | ⤷ Try a Trial |
Hong Kong | 1174576 | 帶有包括雙重功能偏壓部件的延遲機構的自動注射裝置 (AUTOMATIC INJECTION DEVICE WITH DELAY MECHANISM INCLUDING DUAL FUNCTIONING BIASING MEMBER) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOUNJARO (AUTOINJECTOR)
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3242887 | C03242887/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022 |
3242887 | CA 2023 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919 |
3242887 | PA2023504 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
3242887 | 122023000012 | Germany | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
3242887 | LUC00296 | Luxembourg | ⤷ Try a Trial | 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 |