Mounjaro
A dual-incretin therapy for type-2 diabetes and weight management.
Where Tirzepatide is approved
All regulators →Of the three regulators tracked here, the first to approve Tirzepatide was the US, on 13 May 2022. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tirzepatide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tirzepatide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 30 Dec 2041 (US 12295987).
- Latest patent on the drug substance itself: 14 Jun 2039 (US 11357820).
- Exclusivity NPP: New patient population, until 19 Dec 2028.
- Exclusivity I-958: New indication: treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, until 20 Dec 2027.
- Exclusivity M-82: Other exclusivity: labeling revisions related to clinical studies, until 18 Oct 2027.
- Exclusivity NCE: New chemical entity, until 13 May 2027.
- Exclusivity NP: New product, until 8 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Tirzepatide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tirzepatide works
All drug targets →- Gastric inhibitory polypeptide receptor agonist AgonistTarget: GIPR gastric inhibitory polypeptide receptor✓ In ChEMBL and the Guide to Pharmacology
- Glucagon-like peptide 1 receptor agonist AgonistTarget: GLP1R glucagon like peptide 1 receptor✓ In ChEMBL and the Guide to Pharmacology
- Crohn diseasePhase 3
- Obstructive sleep apnea syndromePhase 3
- Psoriasis vulgarisPhase 3
- Psoriatic arthritisPhase 3
- Type 1 diabetes mellitusPhase 3
- Ulcerative colitisPhase 3
- Endometrial Intraepithelial NeoplasiaPhase 2
- Hepatic fibrosisPhase 2
- InfertilityPhase 2
- Insulin resistancePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297839, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 11429, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tirzepatide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Tirzepatide. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tirzepatide for managing overweight and obesity NICE TA1026 | Optimised | 23 Dec 2024 Updated 1 Sep 2025 | Current |
| Tirzepatide for treating type 2 diabetes NICE TA924 | Optimised | 25 Oct 2023 Updated 1 Sep 2025 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tirzepatide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 12 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: MounjaroEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tirzepatide
- ATC code
- A10BX16
- ChEMBL
- CHEMBL4297839
- DrugBank
- DB15171
- PubChem CID
- 156588324
- CAS number
- 2023788-19-2
- FDA UNII
- OYN3CCI6QE
- Wikidata
- Q108324770
- Wikipedia
- Tirzepatide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Mounjaro is used for
MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
How it works
12.1 Mechanism of Action Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1. Tirzepatide enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucose-dependent manner.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.