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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

Drug patent expirations by year for MOUNJARO (AUTOINJECTOR)

Pharmacology for MOUNJARO (AUTOINJECTOR)

Drug Class	GLP-1 Receptor Agonist Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Mechanism of Action	G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists

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
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Glossary

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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
>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)

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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.

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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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MOUNJARO (AUTOINJECTOR)

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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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description