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ZEPBOUND Drug Patent Profile

When do Zepbound patents expire, and when can generic versions of Zepbound launch?

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

DrugPatentWatch^® Generic Entry Outlook for Zepbound

Zepbound 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 ZEPBOUND

International Patents:	110
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ZEPBOUND
What excipients (inactive ingredients) are in ZEPBOUND?	ZEPBOUND excipients list
DailyMed Link:	ZEPBOUND at DailyMed

See drug prices for ZEPBOUND

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

NDA:

217806

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.

Pharmacology for ZEPBOUND

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 ZEPBOUND

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 ZEPBOUND

ZEPBOUND is protected by two US patents and two FDA Regulatory Exclusivities.

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 ZEPBOUND

FDA Regulatory Exclusivity protecting ZEPBOUND

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	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-001	Nov 8, 2023		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-005	Nov 8, 2023		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-006	Nov 8, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for ZEPBOUND

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 ZEPBOUND

When does loss-of-exclusivity occur for ZEPBOUND?

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 ZEPBOUND around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	202092713	КОМПОЗИЦИИ АГОНИСТОВ GIP/GLP1
South Korea	20210010572	GIP/GLP1 작용제 조성물
El Salvador	2017005453	COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1

Supplementary Protection Certificates for ZEPBOUND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	CA 2023 00005	Denmark		PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919
3242887	PA2023504	Lithuania		PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915