MOUNJARO Drug Patent Profile
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Which patents cover Mounjaro, and when can generic versions of Mounjaro launch?
Mounjaro is a drug marketed by Eli Lilly And Co and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and fifteen patent family members in forty-four countries.
The generic ingredient in MOUNJARO is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.
DrugPatentWatch® Generic Entry Outlook for Mounjaro
Mounjaro 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 MOUNJARO
International Patents: | 115 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 3 |
Drug Prices: | Drug price information for MOUNJARO |
What excipients (inactive ingredients) are in MOUNJARO? | MOUNJARO excipients list |
DailyMed Link: | MOUNJARO at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MOUNJARO
Generic Entry Date for MOUNJARO*:
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 MOUNJARO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanderbilt University Medical Center | Phase 2 |
University Health Network, Toronto | Phase 2 |
Eli Lilly and Company | Phase 4 |
Pharmacology for MOUNJARO
US Patents and Regulatory Information for MOUNJARO
MOUNJARO is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MOUNJARO is ⤷ Try for Free.
This potential generic entry date is based on patent 9,474,780.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-005 | May 13, 2022 | RX | Yes | Yes | 11,357,820 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-004 | May 13, 2022 | RX | Yes | Yes | 9,474,780 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-005 | May 13, 2022 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 MOUNJARO
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 MOUNJARO
When does loss-of-exclusivity occur for MOUNJARO?
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: ⤷ Try for Free
Australia
Patent: 16205435
Patent: GIP and GLP-1 co-agonist compounds
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2017010596
Patent: compostos coagonistas de gip e glp-1
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 73352
Patent: COMPOSES CO-AGONISTES DE GIP ET DE GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 17001760
Patent: Compuestos co-agonistas de gip y glp-1
Estimated Expiration: ⤷ Try for Free
China
Patent: 7207576
Patent: GIP和GLP‑1共激动剂化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 2608377
Patent: GIP和GLP-1共激动剂化合物 (GIP and GLP-1 co-agonist compounds)
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Costa Rica
Patent: 170310
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0191614
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 42887
Estimated Expiration: ⤷ Try for Free
Dominican Republic
Patent: 017000153
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 17043648
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷ Try for Free
El Salvador
Patent: 17005453
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 1591
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 5055
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 1791281
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷ Try for Free
Patent: 1892057
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷ Try for Free
Patent: 2090392
Patent: СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 42887
Patent: COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 97662
Patent: COMPOSÉS CO-AGONISTES GIP ET GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Finland
Patent: 0230005
Estimated Expiration: ⤷ Try for Free
France
Patent: C1006
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 45860
Estimated Expiration: ⤷ Try for Free
Patent: 300006
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 2499
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷ Try for Free
Patent: 6492
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷ Try for Free
Patent: 1545
Patent: תרכובות קו-אגוניסטיות ל- gip ו- glp-1 (Gip and glp-1 co-agonist compounds)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 19534
Estimated Expiration: ⤷ Try for Free
Patent: 45766
Estimated Expiration: ⤷ Try for Free
Patent: 54867
Estimated Expiration: ⤷ Try for Free
Patent: 17507124
Patent: GIPおよびGLP−1コアゴニスト化合物
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Jordan
Patent: 0200119
Patent: مركبات مساعد مشترك من GIP وGLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 75
Patent: مركبات مساعد مشترك من GIP وGLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 2023504
Estimated Expiration: ⤷ Try for Free
Patent: 42887
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 3616
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 17008927
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1. (GIP AND GLP-1 CO-AGONIST COMPOUNDS.)
Estimated Expiration: ⤷ Try for Free
Patent: 21005835
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1. (GIP AND GLP-1 CO-AGONIST COMPOUNDS.)
Estimated Expiration: ⤷ Try for Free
Moldova, Republic of
Patent: 42887
Estimated Expiration: ⤷ Try for Free
Montenegro
Patent: 494
Patent: SPOJEVI KOJI SU SUAGONISTI GIP I GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 315
Patent: COMPOSÉS CO-AGONISTES DE GIP ET DE GLP-1
Estimated Expiration: ⤷ Try for Free
Patent: 422
Patent: COMPOSÉS CO-AGONISTES GIP ET GLP-1
Estimated Expiration: ⤷ Try for Free
Netherlands
Patent: 1217
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 2000
Patent: Gip and glp-1 co-agonist compounds
Estimated Expiration: ⤷ Try for Free
Patent: 8274
Patent: Gip and glp-1 co-agonist compounds
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 23005
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 170954
Patent: COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 017501252
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS.
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 42887
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 42887
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 146
Patent: JEDINJENJA KO-AGONISTI GIP I GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 201705603Y
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 42887
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1703930
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1957620
Estimated Expiration: ⤷ Try for Free
Patent: 2330764
Estimated Expiration: ⤷ Try for Free
Patent: 170092661
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 190026967
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 210145311
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Patent: 230023822
Patent: GIP 및 GLP-1 공효능제 화합물 (-1 GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 47928
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 82109
Estimated Expiration: ⤷ Try for Free
Patent: 1636362
Patent: GIP and GLP-1 co-agonist compounds
Estimated Expiration: ⤷ Try for Free
Tunisia
Patent: 17000198
Patent: GIP AND GLP-1 CO-AGONIST COMPOUNDS
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 8239
Patent: СПОЛУКА-КОАГОНІСТ GIP І GLP-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Estimated Expiration: ⤷ Try for Free
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 MOUNJARO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
El Salvador | 2017005453 | COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1 | ⤷ Try for Free |
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 for Free |
Taiwan | 201636362 | GIP and GLP-1 co-agonist compounds | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOUNJARO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3242887 | PA2023504 | Lithuania | ⤷ Try for Free | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
3242887 | CA 2023 00005 | Denmark | ⤷ Try for Free | PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919 |
3242887 | C03242887/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of Mounjaro
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