TheraRadar
Data updated: May 26, 2026

LONHALA MAGNAIR KIT (glycopyrrolate)

Respiratory Approved 2017-12-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-12-05
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
INHALATION
Dosage Forms
SOLUTION

Companies

SUMITOMO PHARMA AM
Active Ingredient: GLYCOPYRROLATE

LONHALA MAGNAIR KIT Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2017 to 2019
Jun 2019 SUPPL
Label · Labeling
FDA Letter Label
Dec 2017 ORIGINAL
Update · Type 3 - New Dosage Form and Type 4 - New Combination
FDA Letter Label

What LONHALA MAGNAIR KIT Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
📋

Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT05887375 2096001 MISP Database number 101357 Ph 4 completed Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
NCT05116930 21-009530 Ph 2 recruiting Neostigmine and Glycopyrrolate for the Treatment of Headache After Dural Puncture
NCT03111121 results posted 1610312153 Ph 4 completed Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
NCT06045364 2023-115 Ph 1, Ph 2 completed Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
NCT03939923 results posted 1806161309 Ph 4 completed Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
NCT03513406 STUDY00141829 Ph 3 completed Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
NCT03322657 results posted 17-764 Ph 4 completed Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
NCT01176851 Gly1 CCD-0915-PR-0031 Ph 1 completed Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
NCT01476813 CCD-1106-PR-0066 Ph 2 completed Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
NCT01176903 GLY2 CCD-0916-PR-0032 2010-018668-18 Ph 1, Ph 2 completed Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration
NCT01398111 TRIPLE 1 CCD-1101-PR-0056 2011-001552-11 Ph 1 completed Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
NCT02574611 KOR-15-026 Ph 1 withdrawn Use of High Resolution Colonic Manometry in Studying Motility
NCT03138967 results posted 2015-1007 Ph 4 completed Investigation of Sugammadex in Outpatient Urological Procedures
NCT02872935 results posted 201301793 Ph 4 terminated Minimizing Nausea and Vomiting During Spinals for CS
NCT03513757 results posted CHW 959242-5 Ph 4 completed Dexmedetomidine and Propofol for Pediatric MRI Sedation
NCT02860507 results posted TGH015 Ph 4 completed Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
NCT02327923 IERB/284/014 Ph 4 completed Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
NCT02375217 ANES.MA.14 Ph 4 completed "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
NCT02613494 GOTHIC1 2015-GOTHIC1 Ph 1, Ph 2 completed Clozapine-induced Hypersalivation - Feasibility Trial
NCT01479764 results posted P07981 MK-8616-064 Ph 3 completed Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
NCT01588717 AIDES-G AIDES-G Ph 1 terminated Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)
NCT01199237 results posted H10722-35629-01 Ph 4 completed Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LONHALA MAGNAIR KIT FDA Label Details

View full patent landscape →
9 OB patents · 8 families · 110 international docs across 12 countries

LONHALA MAGNAIR KIT Patents & Exclusivity

Latest Patent: Dec 2036

Patents (9 active)

US10744277 Expires Dec 7, 2036
US10688518 Expires Nov 12, 2036
US10376661 Expires Sep 14, 2035
US9604018 Expires May 16, 2033
US9168556 Expires Sep 1, 2032
US9789270 Expires Oct 30, 2030
US10940110 Expires Feb 26, 2029
US9265900 Expires Dec 7, 2028
US11278683 Expires Aug 16, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for LONHALA MAGNAIR KIT

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2036
  • • 9 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208437 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.