NDAORALTABLET
Approved
Aug 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
3/8 — Basic
ROBINUL FORTE (glycopyrrolate) by R-Pharm US is tissues, including salivary glands. First approved in 1961.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROBINUL FORTE (glycopyrrolate) is an oral anticholinergic tablet approved in 1961 that reduces salivation and secretions by blocking muscarinic receptors on salivary glands and other tissues. It is indicated for chronic obstructive pulmonary disease (COPD) and neuromuscular blockade reversal. The drug works indirectly by preventing acetylcholine stimulation of parasympathetic receptors.
LOE Approaching
Product approaching loss of exclusivity with minimal active commercial investment; expect team contraction and focus shift to cost management and generic transition planning.
Mechanism of Action
tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
Started Oct 2025
33 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
Started Jul 2025
480 enrolled
Chronic Obstructive Pulmonary Disease
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
Started Aug 2024
46 enrolled
Chronic Obstructive Pulmonary Disease
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
Started Aug 2023
118 enrolled
Spine SurgeryReversal of Neuromuscular BlockadeUrinary Retention Postoperative
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Started Jun 2014
100 enrolled
Chronic Obstructive Pulmonary Disease
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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.