MOUNJARO Drug Patent Profile

Which patents cover Mounjaro, and when can generic versions of Mounjaro launch?

Mounjaro 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 is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mounjaro

Mounjaro 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 5, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MOUNJARO

International Patents:	110
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Drug Prices:	Drug price information for MOUNJARO
What excipients (inactive ingredients) are in MOUNJARO?	MOUNJARO excipients list
DailyMed Link:	MOUNJARO at DailyMed

See drug prices for MOUNJARO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MOUNJARO

NDA:

215866

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MOUNJARO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eli Lilly and Company	Phase 4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 4

See all MOUNJARO clinical trials

Pharmacology for MOUNJARO

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

Anatomical Therapeutic Chemical (ATC) Classes for MOUNJARO

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for MOUNJARO

MOUNJARO is protected by two US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MOUNJARO

FDA Regulatory Exclusivity protecting MOUNJARO

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	215866-005	May 13, 2022		RX	Yes	Yes			Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-004	May 13, 2022		RX	Yes	Yes			Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-005	May 13, 2022		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-004	May 13, 2022		RX	Yes	Yes			Y
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes			Y	Y
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-012	Jul 28, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for MOUNJARO

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

International Patents for MOUNJARO

When does loss-of-exclusivity occur for MOUNJARO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Finland

France

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MOUNJARO around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	252499	תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Argentina	103242	COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
China	112312926	GIP/GLP1激动剂组合物 (GIP/GLP1 AGONIST COMPOSITIONS)
Mexico	2020013727	COMPOSICIONES AGONISTAS DE GIP/GLP1. (GIP/GLP1 AGONIST COMPOSITIONS.)
Poland	3242887
New Zealand	732000	Gip and glp-1 co-agonist compounds

Supplementary Protection Certificates for MOUNJARO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	CA 2023 00005	Denmark		PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919
3242887	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	122023000012	Germany		PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	301217	Netherlands		PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919
3242887	2023C/506	Belgium		PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	LUC00296	Luxembourg		PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919