Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact

← All drugs

Tylenol

Acetaminophen · also sold as Tylenol / Panadol

An oral or rectal medication used to relieve mild-to-moderate pain and reduce fever.

Analgesic and antipyretic
Generic name
Acetaminophen
Brand names
Tylenol / Panadol
Marketed by
Johnson & Johnson
First FDA approval
26 May 1976

Where Acetaminophen is approved

All regulators →

Of the three regulators tracked here, the first to approve Acetaminophen was the US, on 7 Nov 1968. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
7 Nov 1968
Neopap
NDA016401 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
20 Jun 2013
Ofirmev
Notice of Compliance 14485
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.

Acetaminophen patents and exclusivity

Expiry tracker →

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

US FDA Orange Book Acetaminophen, Infants' Feverall, Tylenol
  • 1 listed patent; the last listed expires 19 Apr 2030 (US 8741959).
See the Orange Book listing for NDA 204957
Patents and exclusivities above are pooled across 5 applications for this substance.

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 Acetaminophen

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$70.7m
7,500,589 prescriptions in 2025 · Acetaminophen, Rugby Regular Strength Acetaminophen, acetaminophen
-4% on 2024
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 Acetaminophen works

All drug targets →
  • Cyclooxygenase inhibitor Inhibitor
    Target: Cyclooxygenase
    ✓ In ChEMBL and the Guide to Pharmacology
  • Anandamide amidohydrolase inhibitor Inhibitor
    Target: FAAH fatty acid amide hydrolase
    ChEMBL only
  • Vanilloid receptor opener Opener
    Target: TRPV1 transient receptor potential cation channel subfamily V member 1
    ChEMBL only
Other medicines acting on TRPV1
Diseases it has been tested for in clinical trials, by furthest phase
  • Abdominal painPhase 3
  • COVID-19Phase 3
  • Cholecystitis, AcutePhase 3
  • Chronic painPhase 3
  • Inguinal herniaPhase 3
  • Low back painPhase 3
  • NauseaPhase 3
  • Patent ductus arteriosusPhase 3
  • SepsisPhase 3
  • SneezePhase 3
69 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL112, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5239, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Acetaminophen

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

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-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 Acetaminophen

ATC code
N02BE01
ChEMBL
CHEMBL112
DrugBank
DB00316
PubChem CID
1983
CAS number
103-90-2
FDA UNII
362O9ITL9D
Wikidata
Q57055
Wikipedia
Paracetamol

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 Tylenol is used for

Acetaminophen (Tylenol / Panadol) is an oral or rectal medication used to relieve mild-to-moderate pain and reduce fever. It belongs to the Analgesic and antipyretic class.

Related clinical trials recruiting now

Compare Tylenol with

Explore more

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 5 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.