Tirzepatide - Generic Drug Details
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What are the generic sources for tirzepatide and what is the scope of patent protection?
Tirzepatide
is the generic ingredient in four branded drugs marketed by Eli Lilly And Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tirzepatide has one hundred and eleven patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for tirzepatide
International Patents: | 111 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 61 |
What excipients (inactive ingredients) are in tirzepatide? | tirzepatide excipients list |
DailyMed Link: | tirzepatide at DailyMed |
Recent Clinical Trials for tirzepatide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vanderbilt University Medical Center | Phase 2 |
University Health Network, Toronto | Phase 2 |
Royal North Shore Hospital | Phase 2 |
Pharmacology for tirzepatide
Drug Class | GLP-1 Receptor Agonist Glucose-dependent Insulinotropic Polypeptide Receptor Agonist |
Mechanism of Action | G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for tirzepatide
US Patents and Regulatory Information for tirzepatide
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 | 217806-004 | 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 | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-003 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-002 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Eli Lilly And Co | MOUNJARO | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-007 | Jul 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Eli Lilly And Co | ZEPBOUND | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-012 | Mar 28, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | MOUNJARO | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-007 | Jul 28, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 tirzepatide
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 tirzepatide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Moldova, Republic of | 3242887 | ⤷ Sign Up | |
Croatia | P20230748 | ⤷ Sign Up | |
South Korea | 102330764 | ⤷ Sign Up | |
Australia | 2019289110 | GIP/GLP1 agonist compositions | ⤷ Sign Up |
Ecuador | SP20082717 | COMPOSICIONES AGONISTAS DE GIP/GLP1 | ⤷ Sign Up |
China | 112608377 | GIP和GLP-1共激动剂化合物 (GIP and GLP-1 co-agonist compounds) | ⤷ Sign Up |
Ecuador | SP17043648 | COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tirzepatide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | CA 2023 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919 |
3242887 | LUC00296 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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