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Seebri Breezhaler

Glycopyrronium

An inhaled maintenance therapy used to open airways and ease breathing in COPD.

Generic name
Glycopyrronium
Brand name
Seebri Breezhaler
Marketed by
Journey Medical
First FDA approval
28 Jun 2018

Where Glycopyrronium is approved

All regulators →

Of the three regulators tracked here, the first to approve Glycopyrronium was the EU, on 28 Sep 2012. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
28 Jun 2018
Qbrexza
NDA210361 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
28 Sep 2012
Enurev Breezhaler
EMA product page
First centralised authorisation
CACanada (Health Canada)
16 Oct 2012
Seebri Breezhaler
Notice of Compliance 13729
First new-drug NOC

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.

Glycopyrronium patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Glycopyrronium, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Qbrexza
  • 8 listed patents; the last listed expires 28 Feb 2033 (US 8859610).
  • Latest patent on the drug substance itself: 28 Feb 2033 (US 10548875).
See the Orange Book listing for NDA 210361

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 Glycopyrronium

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ENNHS England
£27.8m
323,418 items dispensed, Aug 2025 to Jul 2026
-16% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
No single-ingredient product reimbursed by Medicaid in 2025
Amount Medicaid reimbursed, before rebates

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 Glycopyrronium works

All drug targets →
  • Muscarinic acetylcholine receptor M3 antagonist Antagonist
    Target: CHRM3 cholinergic receptor muscarinic 3
    ✓ In ChEMBL and the Guide to Pharmacology
  • Muscarinic acetylcholine receptor M1 antagonist Antagonist
    Target: CHRM1 cholinergic receptor muscarinic 1
    ✓ In ChEMBL and the Guide to Pharmacology
  • Muscarinic acetylcholine receptor inhibitor Inhibitor
    Target: Muscarinic acetylcholine receptor
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on CHRM1
Diseases it has been tested for in clinical trials, by furthest phase
  • HyperhidrosisPhase 3
  • Nasopharyngeal carcinomaPhase 3
  • Non-small cell lung carcinomaPhase 2
  • Diabetes mellitusPhase 1/2

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201335, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7459, 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 Glycopyrronium

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Glycopyrronium. 1 is current, and 1 of it recommends it for at least some patients.

AppraisalNICE recommendationPublishedStatus
Glycopyrronium bromide cream for treating severe primary axillary hyperhidrosis
NICE TA1175
Optimised9 Jul 2026Current

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 Glycopyrronium

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

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 Glycopyrronium

ATC codes
R03BB06, A03AB02
ChEMBL
CHEMBL1201335
DrugBank
DB00986
PubChem CID
3494
CAS number
13283-82-4
Wikidata
Q411917

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 Seebri Breezhaler is used for

Glycopyrronium (Seebri Breezhaler) is an inhaled maintenance therapy used to open airways and ease breathing in COPD. It belongs to the Anticholinergic bronchodilator class.

Related clinical trials recruiting now

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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.

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 11 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.