NDAINHALATIONAEROSOL, METERED
Approved
Sep 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
ATROPINE SULFATE (atropine sulfate) by Medica Corp is muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent. First approved in 1990.
Drug data last refreshed 20m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Atropine Sulfate is an antimuscarinic agent administered as a metered-dose aerosol inhalation that blocks muscarine-like actions of acetylcholine at muscarinic receptors. It is used to produce mydriasis (pupil dilation) and cycloplegia (loss of accommodation) by preventing muscarinic receptor activation in ocular and respiratory tissues. The drug has been in clinical use since 1990 and remains a standard agent in ophthalmology and emergency medicine.
$0.017MPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Medicare Part D claims suggests a mature, low-volume market with limited commercial team expansion.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.