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Last Updated: April 24, 2024

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 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

Generic Entry Dates for tirzepatide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for tirzepatide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-004	Nov 8, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-005	May 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-003	May 13, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-011	Jul 28, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-009	Jul 28, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Eli Lilly And Co	ZEPBOUND	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-002	Nov 8, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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
Montenegro	03494	SPOJEVI KOJI SU SUAGONISTI GIP I GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)	⤷ Try a Trial
Taiwan	201636362	GIP and GLP-1 co-agonist compounds	⤷ Try a Trial
Japan	7413315		⤷ Try a Trial
Ukraine	118239	СПОЛУКА-КОАГОНІСТ GIP І GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)	⤷ Try a Trial
Ecuador	SP20082717	COMPOSICIONES AGONISTAS DE GIP/GLP1	⤷ Try a Trial
Chile	2020003359	Composiciones agonistas de gip/glp1	⤷ Try a Trial
>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	C03242887/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	301217	Netherlands	⤷ Try a Trial	PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919
3242887	2023C/506	Belgium	⤷ Try a Trial	PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	CA 2023 00005	Denmark	⤷ Try a Trial	PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919
3242887	LUC00296	Luxembourg	⤷ Try a Trial	PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	122023000012	Germany	⤷ Try a Trial	PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.