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Last Updated: December 4, 2024

Tirzepatide - Generic Drug Details


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What are the generic drug 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*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for tirzepatide*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Vanderbilt University Medical CenterPhase 2
University Health Network, TorontoPhase 2
Royal North Shore HospitalPhase 2

See all tirzepatide clinical trials

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 ZEPBOUND tirzepatide SOLUTION;SUBCUTANEOUS 217806-011 Mar 28, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eli Lilly And Co MOUNJARO (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 215866-006 May 13, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-005 Nov 8, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co ZEPBOUND tirzepatide SOLUTION;SUBCUTANEOUS 217806-009 Mar 28, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-003 Nov 8, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co MOUNJARO tirzepatide SOLUTION;SUBCUTANEOUS 215866-010 Jul 28, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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

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

Country Patent Number Title Estimated Expiration
South Korea 102523489 ⤷  Sign Up
Mexico 2020013727 COMPOSICIONES AGONISTAS DE GIP/GLP1. (GIP/GLP1 AGONIST COMPOSITIONS.) ⤷  Sign Up
Japan 2018052933 GIPおよびGLP−1コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) ⤷  Sign Up
Eurasian Patent Organization 035055 СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) ⤷  Sign Up
Brazil 112017010596 compostos coagonistas de gip e glp-1 ⤷  Sign Up
Serbia 64288 KOMPOZICIJE AGONISTI GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS) ⤷  Sign Up
China 107207576 GIP和GLP‑1共激动剂化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tirzepatide

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 2023C/506 Belgium ⤷  Sign Up PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887 301217 Netherlands ⤷  Sign Up PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION 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
3242887 PA2023504 Lithuania ⤷  Sign Up PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887 CA 2023 00005 Denmark ⤷  Sign Up PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919
>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.