Data updated: Mar 10, 2026
PYRIDOSTIGMINE BROMIDE
PYRIDOSTIGMINE BROMIDE
Approved 1990-11-27
16
Indications
--
Phase 3 Trials
1
Priority Reviews
35
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1990-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, SYRUP
Companies
IMPAX LABS INC ANI PHARMS NOVITIUM PHARMA SOLVAY ZYDUS PHARMS US ARMY MLV AMNEAL ALVOGEN RISING MILLA PHARMS MSN IMPAX LABS
Active Ingredient: PYRIDOSTIGMINE BROMIDE
Website: ↗
PYRIDOSTIGMINE BROMIDE Approval History
Loading approval history...
What PYRIDOSTIGMINE BROMIDE Treats
16 FDA approvalsOriginally approved for its first indication in 1990 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Nov 1990)
- • Approved indication (Dec 2002)
- • Approved indication (Feb 2003) PriorityLabel Letter
- • Approved indication (Apr 2003)
- • Approved indication (Oct 2003)
- • Approved indication (Jun 2015)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Sep 2015)
- • Approved indication (Aug 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Mar 2019)Letter
- • Approved indication (Jan 2020)
- • Approved indication (Jan 2020)Letter
- • Approved indication (Apr 2022)
- • Approved indication (Sep 2023)
- • Approved indication (Oct 2024)Label Letter
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
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.
PYRIDOSTIGMINE BROMIDE FDA Label Details
ProPYRIDOSTIGMINE 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
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.