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Last Updated: May 18, 2024

ZEPBOUND (AUTOINJECTOR) Drug Patent Profile


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Which patents cover Zepbound (autoinjector), and when can generic versions of Zepbound (autoinjector) launch?

Zepbound (autoinjector) 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 (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.

DrugPatentWatch® Generic Entry Outlook for Zepbound (autoinjector)

Zepbound (autoinjector) 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.

Indicators of Generic Entry

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Summary for ZEPBOUND (AUTOINJECTOR)
International Patents:111
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:ZEPBOUND (AUTOINJECTOR) at DailyMed
Drug patent expirations by year for ZEPBOUND (AUTOINJECTOR)

US Patents and Regulatory Information for ZEPBOUND (AUTOINJECTOR)

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

Patents protecting ZEPBOUND (AUTOINJECTOR)

GIP/GLP1 agonist compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ZEPBOUND (AUTOINJECTOR)

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  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
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-006 Nov 8, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-006 Nov 8, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co ZEPBOUND (AUTOINJECTOR) tirzepatide SOLUTION;SUBCUTANEOUS 217806-001 Nov 8, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 ZEPBOUND (AUTOINJECTOR)

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 (AUTOINJECTOR)

See the table below for patents covering ZEPBOUND (AUTOINJECTOR) around the world.

Country Patent Number Title Estimated Expiration
Taiwan I705820 ⤷  Try a Trial
Eurasian Patent Organization 031591 СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) ⤷  Try a Trial
Eurasian Patent Organization 201791281 СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPBOUND (AUTOINJECTOR)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3242887 PA2023504 Lithuania ⤷  Try a Trial PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887 LUC00296 Luxembourg ⤷  Try a Trial PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887 301217 Netherlands ⤷  Try a Trial 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.