Tagrisso
A targeted oral therapy for EGFR-mutated non-small-cell lung cancer.
Where Osimertinib is approved
All regulators →Of the three regulators tracked here, the first to approve Osimertinib was the US, on 13 Nov 2015. It is approved in 2 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.
Osimertinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Osimertinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 26 Nov 2042 (US 12465608).
- Latest patent on the drug substance itself: 8 Aug 2032 (US 8946235).
- Exclusivity ODE-337: Orphan drug exclusivity: for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors …, until 18 Dec 2027.
- Exclusivity I-952: New indication: treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose diseas…, until 25 Sep 2027.
- Exclusivity I-941: New indication: in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally …, until 16 Feb 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 Osimertinib
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 Osimertinib works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- CancerPhase 3
- Lung cancerPhase 3
- MelanomaPhase 3
- Breast cancerPhase 2
- GlioblastomaPhase 2
- Leptomeningeal metastasisPhase 2
- Lung adenocarcinomaPhase 2
- LymphomaPhase 2
- Malignant pancreatic neoplasmPhase 2
- Non-small cell lung adenocarcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3353410, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7719, 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 Osimertinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Osimertinib. 8 are current, and 5 of these recommend it for at least some patients.
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 Osimertinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TagrissoEMA 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 Osimertinib
- ATC code
- L01XE35
- ChEMBL
- CHEMBL3353410
- DrugBank
- DB09330
- PubChem CID
- 71496458
- CAS number
- 1421373-65-0
- FDA UNII
- 3C06JJ0Z2O
- Wikidata
- Q21506464
- Wikipedia
- Osimertinib
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 Tagrisso is used for
Osimertinib (Tagrisso) is a targeted oral therapy for EGFR-mutated non-small-cell lung cancer. It belongs to the EGFR inhibitor class.
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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 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.