Tirzepatide - Generic Drug Details

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What are the generic sources for tirzepatide and what is the scope of freedom to operate?

Tirzepatide is the generic ingredient in four branded drugs marketed by Eli Lilly And Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirzepatide has one hundred and eleven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for tirzepatide

International Patents:	111
US Patents:	3
Tradenames:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	61
What excipients (inactive ingredients) are in tirzepatide?	tirzepatide excipients list
DailyMed Link:	tirzepatide at DailyMed

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

Generic Entry Dates for tirzepatide^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for tirzepatide^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 tirzepatide

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2
University Health Network, Toronto	Phase 2
Royal North Shore Hospital	Phase 2

See all tirzepatide clinical trials

Pharmacology for tirzepatide

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 tirzepatide

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 tirzepatide

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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	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-010	Jul 28, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-004	Nov 8, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-008	Mar 28, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-006	Nov 8, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-008	Mar 28, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-011	Mar 28, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-009	Jul 28, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 tirzepatide

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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 tirzepatide

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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
South Korea	20230023822	ＧＩＰ 및 ＧＬＰ-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)	⤷ Sign Up
Taiwan	I582109		⤷ Sign Up
Costa Rica	20200634	COMPOSICIONES AGONISTAS DE GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS)	⤷ Sign Up
El Salvador	2017005453	COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1	⤷ Sign Up
South Korea	20190026967	ＧＩＰ 및 ＧＬＰ-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)	⤷ Sign Up
Finland	C20230005		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tirzepatide

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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
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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