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 |
-patent-expirations.png "ZEPBOUND (AUTOINJECTOR) drug patent expirations")
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: ⤷ 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 (AUTOINJECTOR)
NEW PRODUCT
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 | 217806-006 | Nov 8, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eli Lilly And Co | ZEPBOUND (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-006 | 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 | ⤷ Sign Up | ||||
| Eli Lilly And Co | ZEPBOUND (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-004 | Nov 8, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-002 | 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 (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 |
|---|---|---|---|
| Japan | 2019203000 | ＧＩＰおよびＧＬＰ−１コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUND) | ⤷ Sign Up |
| Japan | 2015128606 | 二重機能付勢部材を含む遅延機構を備える自動注入装置 (AUTOMATIC INJECTOR DEVICE WITH DELAY MECHANISM INCLUDING DUAL FUNCTIONING BIASING MEMBER) | ⤷ Sign Up |
| Eurasian Patent Organization | 201892057 | СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 | ⤷ Sign Up |
| Netherlands | 301217 | ⤷ Sign Up | |
| Israel | 252499 | תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds) | ⤷ Sign Up |
| Dominican Republic | P2017000153 | COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEPBOUND (AUTOINJECTOR)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3242887 | 2023C/506 | Belgium | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND 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 | 301217 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/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 |
| >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.
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