NDAINTRAVENOUSSOLUTION
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
ATROPINE SULFATE (atropine sulfate) by Accord Biopharma is muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. Approved for myopia. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Atropine Sulfate is an antimuscarinic agent that blocks muscarinic acetylcholine receptors to treat myopia by inducing mydriasis (pupil dilation) and cycloplegia (ciliary muscle paralysis). Available as an intravenous solution, it competitively antagonizes acetylcholine at peripheral muscarinic receptor sites. This well-established mechanism makes it suitable for ophthalmologic applications where pupil and accommodation control are therapeutically relevant.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30%), suggesting stable but not expanding team sizes in marketing and sales functions.
Mechanism of Action
muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. Atropine is relatively selective for muscarinic receptors. Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically. Atropine does…
Indications (1)
Clinical Trials (3)
A Study of Atropine Sulfate in Healthy Chinese Volunteers
Started May 2023
30 enrolled
Pharmacokinetics
A Phase III Clinical Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Started May 2022
526 enrolled
Myopia
A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
Started Mar 2022
777 enrolled
Myopia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.