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.
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
Summary for ZEPBOUND
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Drug Prices: | Drug price information for ZEPBOUND |
What excipients (inactive ingredients) are in ZEPBOUND? | ZEPBOUND excipients list |
DailyMed Link: | ZEPBOUND at DailyMed |
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.
Pharmacology for ZEPBOUND
Anatomical Therapeutic Chemical (ATC) Classes for ZEPBOUND
US Patents and Regulatory Information for ZEPBOUND
ZEPBOUND is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPBOUND is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting ZEPBOUND
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 16205435
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017010596
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 73352
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17001760
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7207576
Estimated Expiration: ⤷ Try a Trial
Patent: 2608377
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17006737
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 170310
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191614
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 017000153
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17043648
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 17005453
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1591
Estimated Expiration: ⤷ Try a Trial
Patent: 5055
Estimated Expiration: ⤷ Try a Trial
Patent: 1791281
Estimated Expiration: ⤷ Try a Trial
Patent: 1892057
Estimated Expiration: ⤷ Try a Trial
Patent: 2090392
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Patent: 97662
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 0230005
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1006
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 45860
Estimated Expiration: ⤷ Try a Trial
Patent: 300006
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2499
Estimated Expiration: ⤷ Try a Trial
Patent: 6492
Estimated Expiration: ⤷ Try a Trial
Patent: 1545
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 19534
Estimated Expiration: ⤷ Try a Trial
Patent: 45766
Estimated Expiration: ⤷ Try a Trial
Patent: 54867
Estimated Expiration: ⤷ Try a Trial
Patent: 17507124
Estimated Expiration: ⤷ Try a Trial
Patent: 18052933
Estimated Expiration: ⤷ Try a Trial
Patent: 19203000
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 0200119
Estimated Expiration: ⤷ Try a Trial
Patent: 75
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 2023504
Estimated Expiration: ⤷ Try a Trial
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3616
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17008927
Estimated Expiration: ⤷ Try a Trial
Patent: 21005835
Estimated Expiration: ⤷ Try a Trial
Moldova, Republic of
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 494
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 315
Estimated Expiration: ⤷ Try a Trial
Patent: 422
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1217
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2000
Estimated Expiration: ⤷ Try a Trial
Patent: 8274
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 23005
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 170954
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017501252
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 146
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201705603Y
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 42887
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1703930
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1957620
Estimated Expiration: ⤷ Try a Trial
Patent: 2330764
Estimated Expiration: ⤷ Try a Trial
Patent: 170092661
Estimated Expiration: ⤷ Try a Trial
Patent: 190026967
Estimated Expiration: ⤷ Try a Trial
Patent: 210145311
Estimated Expiration: ⤷ Try a Trial
Patent: 230023822
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 47928
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 82109
Estimated Expiration: ⤷ Try a Trial
Patent: 1636362
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 17000198
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 8239
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Colombia | 2017006737 | 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 | ⤷ Try a Trial |
Moldova, Republic of | 3810201 | ⤷ Try a Trial | |
Canada | 2882581 | DISPOSITIF D'INJECTION AUTOMATIQUE A MECANISME A RETARD COMPORTANT UN ELEMENT DE SOLLICITATION A DOUBLE FONCTION (AUTOMATIC INJECTION DEVICE WITH DELAY MECHANISM INCLUDING DUAL FUNCTIONING BIASING MEMBER) | ⤷ Try a Trial |
Costa Rica | 20200634 | COMPOSICIONES AGONISTAS DE GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS) | ⤷ Try a Trial |
Brazil | 112020023452 | composições de agonista de gip/glp1 | ⤷ Try a Trial |
Morocco | 50422 | COMPOSÉS CO-AGONISTES GIP ET GLP-1 | ⤷ Try a Trial |
South Korea | 101419160 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEPBOUND
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
3242887 | 2023C/506 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATIDE; 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 |
3242887 | C03242887/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022 |
3242887 | PA2023504 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
3242887 | CA 2023 00005 | Denmark | ⤷ Try a Trial | 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 |