Ozempic
A GLP-1 therapy for type-2 diabetes and, as Wegovy, chronic weight management.
Where Semaglutide is approved
All regulators →Of the three regulators tracked here, the first to approve Semaglutide was the US, on 5 Dec 2017. It is approved in 3 of the 3 regulators tracked here.
- 5 EU safety letters (DHPC), latest: medication error for Rybelsus, 1 Aug 2025
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.
Semaglutide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Semaglutide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 30 listed patents; the last listed expires 17 Feb 2041 (US 11318191).
- Latest patent on the drug substance itself: 2 May 2034 (US 10278923).
- Exclusivity NS: New strength, until 19 Mar 2029.
- Exclusivity NP: New product, until 22 Dec 2028.
- Exclusivity I-976: New indication: to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fat…, until 17 Oct 2028.
- Exclusivity I-973: New indication: treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohep…, until 15 Aug 2028.
- Exclusivity I-961: New indication: to reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, and cardiova…, until 28 Jan 2028.
- Exclusivity I-935: New indication: in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascul…, until 8 Mar 2027.
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 Semaglutide
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 Semaglutide works
All drug targets →- Glucagon-like peptide 1 receptor agonist AgonistTarget: GLP1R glucagon like peptide 1 receptor✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- HyperglycemiaPhase 3
- Increased body weightPhase 3
- Klinefelter syndromePhase 3
- AlbuminuriaPhase 3
- Atrial fibrillationPhase 3
- Chronic kidney diseasePhase 3
- Coronary atherosclerosisPhase 3
- DementiaPhase 3
- Diabetic retinopathyPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108724, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 9724, 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 Semaglutide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Semaglutide. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Semaglutide for reducing the risk of major adverse cardiovascular events in people with cardiovascular disease and overweight or obesity NICE TA1152 | Recommended | 7 May 2026 | Current |
| Semaglutide for managing overweight and obesity in young people aged 12 to 17 years (terminated appraisal) NICE TA910 | Terminated (no company submission) | 13 Jul 2023 | Current |
| Semaglutide for managing overweight and obesity NICE TA875 | Optimised | 8 Mar 2023 Updated 4 Sep 2023 | 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 Semaglutide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 33 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- 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.
What Ozempic is used for
OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) • to reduce the risk of sustained eGFR decline, end-stage…
How it works
12.1 Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secreti…
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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.