Data updated: Jun 28, 2026
PYRIDOSTIGMINE BROMIDE · US ARMY
CNS
Approved 1955-04-06
Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.
16
Indications
--
Phase 3 Trials
1
Priority Reviews
71
Years on Market
Details
- Status
- Prescription
- First Approved
- 1955-04-06
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE, SYRUP
Companies
US ARMY SOLVAY RISING NOVITIUM PHARMA ZYDUS PHARMS MSN IMPAX LABS MLV MILLA PHARMS AMNEAL ANI PHARMS ALVOGEN
Active Ingredient: PYRIDOSTIGMINE BROMIDE
Website: ↗
PYRIDOSTIGMINE BROMIDE Approval History
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Original
New Indication
New Form
Label Update
29 FDA actions from 1990 to 2026
Sep 2023 ORIGINAL
Update
Apr 2022 ORIGINAL
Update
Jan 2020 ORIGINAL
Update
Jul 2018 ORIGINAL
Update
Aug 2017 ORIGINAL
Update
Dec 2015 SUPPL Priority
Mfg
Sep 2015 ORIGINAL
Update
Jun 2015 ORIGINAL
Update
Sep 2014 SUPPL Priority
Mfg
Jan 2014 SUPPL Priority
Mfg
Oct 2010 SUPPL
Label
Jul 2005 SUPPL
Label
Oct 2003 ORIGINAL
Update
Apr 2003 ORIGINAL
Update
Dec 2002 ORIGINAL
Update
Nov 1990 ORIGINAL
Update
What PYRIDOSTIGMINE BROMIDE Treats
1 indicationsPYRIDOSTIGMINE BROMIDE is approved for 1 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myasthenia Gravis
Same approved indications as MESTINON (same active ingredient).
Source: FDA Label
📋
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05603715 | STUDY00001877 | Ph 2 | recruiting | Pyridostigmine for the Treatment of Constipation in Parkinson Disease |
| NCT05334485 PESTI | 21-915 | Ph 2, Ph 3 | recruiting | Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery |
| NCT02893553 results posted | WEC-16-015 | Ph 2 | completed | The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury |
| NCT02227823 EMOTAS | 1376 | Ph 2 | completed | Safety and Efficacy Study of Pyridostigmine on Patients With Spinal Muscular Atrophy Type 3 |
| NCT03674541 results posted | 2018P001871 | Ph 2 | completed | The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome |
| NCT02308124 results posted | 1409066609 | Ph 4 | completed | Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study |
| NCT01993680 | KEK-ZH-NR. 2011-0358 | Ph 2 | completed | Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment |
| NCT03312244 | Ref. 1873 | Ph 2 | suspended | Pyridostigmine as Immunomodulator in People Living With HIV |
| NCT01415921 APP-HF results posted | 10-02167 10-02167, 1R01HL103988 | Ph 2 | completed | Safety Study of Pyridostigmine in Heart Failure |
| NCT02307526 results posted | WEC-11-04 | Ph 2 | completed | Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
PYRIDOSTIGMINE BROMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.
View full patent landscape →
9 OB patents · 4 families ·
56 international docs across 8 countries
PYRIDOSTIGMINE BROMIDE Patents & Exclusivity
Latest Patent: Jun 2038
Patents (9 active)
US11478425
Expires Jun 18, 2038
US12042559
Expires Jun 18, 2038
US10925833
Expires Jun 18, 2038
US12233166
Expires Jun 18, 2038
US10987311
Expires Jun 18, 2038
US10881617
Expires Jun 18, 2038
US11666536
Expires Jun 18, 2038
US11911515
Expires Jun 18, 2038
US11229606
Expires Jun 18, 2038
Source: FDA Orange Book
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 9 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.