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Last Updated: December 10, 2024

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ZEPBOUND Drug Patent Profile


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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 three patents protecting this drug.

This drug has one hundred and eleven 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

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Summary for ZEPBOUND
International Patents:111
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for ZEPBOUND
What excipients (inactive ingredients) are in ZEPBOUND?ZEPBOUND excipients list
DailyMed Link:ZEPBOUND at DailyMed
Drug patent expirations by year for ZEPBOUND
Drug Prices for ZEPBOUND

See drug prices for ZEPBOUND

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEPBOUND
Generic Entry Date for ZEPBOUND*:
Constraining patent/regulatory exclusivity:
NDA:
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 ZEPBOUND

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

SponsorPhase
Vanderbilt University Medical CenterPhase 2

See all ZEPBOUND clinical trials

US Patents and Regulatory Information for ZEPBOUND

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPBOUND is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

GIP/GLP1 agonist compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH AN INITIAL BODY MASS INDEX (BMI) OF: 30 KG/M2 OR GREATER (OBESITY), OR 27 KG/M2 OR GREATER (OVERWEIGHT) IN THE PRESENCE OF AT LEAST ONE WEIGHT-RELATED COMORBID CONDITION

GIP and GLP-1 co-agonist compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting ZEPBOUND

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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 (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-002 Nov 8, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-001 Nov 8, 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 (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-005 Nov 8, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-003 Nov 8, 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 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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 3242
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 16205435
Patent: GIP and GLP-1 co-agonist compounds
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017010596
Patent: compostos coagonistas de gip e glp-1
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 73352
Patent: COMPOSES CO-AGONISTES DE GIP ET DE GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17001760
Patent: Compuestos co-agonistas de gip y glp-1
Estimated Expiration: ⤷  Sign Up

China

Patent: 7207576
Patent: GIP和GLP‑1共激动剂化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 2608377
Patent: GIP和GLP-1共激动剂化合物 (GIP and GLP-1 co-agonist compounds)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17006737
Patent: Análogos de gip y glp-1 en donde la lisina (k) en la posición 20 está químicamente modificada a través de la conjugación al grupo épsilon-amino de la cadena lateral k con ([2-(2-amino-etoxi)-etoxi]-acetil)2-(γglu)a-co-(ch2)b-co2h activos como agonistas de receptores gip y gip-1
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 170310
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191614
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 42887
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 017000153
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17043648
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

El Salvador

Patent: 17005453
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1591
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 5055
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 1791281
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷  Sign Up

Patent: 1892057
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷  Sign Up

Patent: 2090392
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 42887
Patent: COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 97662
Patent: COMPOSÉS CO-AGONISTES GIP ET GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0230005
Estimated Expiration: ⤷  Sign Up

France

Patent: C1006
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 45860
Estimated Expiration: ⤷  Sign Up

Patent: 300006
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2499
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷  Sign Up

Patent: 6492
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷  Sign Up

Patent: 1545
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19534
Estimated Expiration: ⤷  Sign Up

Patent: 45766
Estimated Expiration: ⤷  Sign Up

Patent: 54867
Estimated Expiration: ⤷  Sign Up

Patent: 17507124
Patent: GIPおよびGLP−1コアゴニスト化合物
Estimated Expiration: ⤷  Sign Up

Patent: 18052933
Patent: GIPおよびGLP−1コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 19203000
Patent: GIPおよびGLP−1コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUND)
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 0200119
Patent: مركبات مساعد مشترك من GIP وGLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 75
Patent: مركبات مساعد مشترك من GIP وGLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 2023504
Estimated Expiration: ⤷  Sign Up

Patent: 42887
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3616
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17008927
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1. (GIP AND GLP-1 CO-AGONIST COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 21005835
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1. (GIP AND GLP-1 CO-AGONIST COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 42887
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 494
Patent: SPOJEVI KOJI SU SUAGONISTI GIP I GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 315
Patent: COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1
Estimated Expiration: ⤷  Sign Up

Patent: 422
Patent: COMPOSÉS CO-AGONISTES GIP ET GLP-1
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1217
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2000
Patent: Gip and glp-1 co-agonist compounds
Estimated Expiration: ⤷  Sign Up

Patent: 8274
Patent: Gip and glp-1 co-agonist compounds
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 23005
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 170954
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017501252
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS.
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 42887
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 42887
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 146
Patent: JEDINJENJA KO-AGONISTI GIP I GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201705603Y
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 42887
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1703930
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1957620
Estimated Expiration: ⤷  Sign Up

Patent: 2330764
Estimated Expiration: ⤷  Sign Up

Patent: 170092661
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 190026967
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 210145311
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 230023822
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 47928
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 82109
Estimated Expiration: ⤷  Sign Up

Patent: 1636362
Patent: GIP and GLP-1 co-agonist compounds
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 17000198
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 8239
Patent: СПОЛУКА-КОАГОНІСТ GIP І GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

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 035055 СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) ⤷  Sign Up
Japan 6545766 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016111971 ⤷  Sign Up
Spain 2953740 ⤷  Sign Up
Australia 2013260666 ⤷  Sign Up
Australia 2016205435 GIP and GLP-1 co-agonist compounds ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPBOUND

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
3242887 PA2023504 Lithuania ⤷  Sign Up PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
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
>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.