Tirzepatide - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for tirzepatide and what is the scope of freedom to operate?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tirzepatide
Generic Entry Dates for tirzepatide*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
Generic Entry Dates for tirzepatide*:
Constraining patent/regulatory exclusivity:
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 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 | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-011 | Mar 28, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Eli Lilly And Co | MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-006 | May 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Eli Lilly And Co | ZEPBOUND | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-008 | Mar 28, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-009 | Mar 28, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Eli Lilly And Co | ZEPBOUND (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806-003 | Nov 8, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eli Lilly And Co | MOUNJARO | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866-010 | Jul 28, 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 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 |
---|---|---|---|
South Korea | 102523489 | ⤷ Sign Up | |
Mexico | 2020013727 | COMPOSICIONES AGONISTAS DE GIP/GLP1. (GIP/GLP1 AGONIST COMPOSITIONS.) | ⤷ Sign Up |
Japan | 2018052933 | GIPおよびGLP−1コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) | ⤷ Sign Up |
Eurasian Patent Organization | 035055 | СОЕДИНЕНИЯ-КОАГОНИСТЫ ГИП И ГПП-1 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) | ⤷ Sign Up |
Brazil | 112017010596 | compostos coagonistas de gip e glp-1 | ⤷ Sign Up |
Serbia | 64288 | KOMPOZICIJE AGONISTI GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS) | ⤷ Sign Up |
China | 107207576 | GIP和GLP‑1共激动剂化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS) | ⤷ 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 | 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 | 301217 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/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 | PA2023504 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915 |
3242887 | CA 2023 00005 | Denmark | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.