TIRZEPATIDE - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for TIRZEPATIDE

International Patents:	110
US Patents:	2
Tradenames:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	51
What excipients (inactive ingredients) are in TIRZEPATIDE?	TIRZEPATIDE excipients list
DailyMed Link:	TIRZEPATIDE at DailyMed

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

Dosage:

SOLUTION;SUBCUTANEOUS

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
Dr Adnan Agha	Phase 1/Phase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 4
Ospedale San Raffaele	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

US Patents and Regulatory Information for TIRZEPATIDE

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	215866-006	May 13, 2022		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-006	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-001	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-001	May 13, 2022		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-003	Nov 8, 2023		RX	Yes	Yes			Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-003	May 13, 2022		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for TIRZEPATIDE

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 TIRZEPATIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2019203000	ＧＩＰおよびＧＬＰ−１コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUND)
South Korea	20230058172	GIP/GLP1 작용제 조성물 (GIP/GLP1 GIP/GLP1 AGONIST COMPOSITIONS)
Norway	2023005
Mexico	2020013727	COMPOSICIONES AGONISTAS DE GIP/GLP1. (GIP/GLP1 AGONIST COMPOSITIONS.)
Jordan	P20200119	مركبات مساعد مشترك من GIP وGLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Taiwan	I582109
Croatia	P20230748

Supplementary Protection Certificates for TIRZEPATIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	PA2023504	Lithuania		PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; 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	LUC00296	Luxembourg		PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	2023C/506	Belgium		PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
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	122023000012	Germany		PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915