Data updated: Nov 8, 2026
MIRAPEX ER (pramipexole dihydrochloride) · Boehringer Ingelheim
CNS
Approved 2010-02-19
3
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-02-19
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
MIRAPEX ER Approval History
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
103 FDA actions from 2010 to 2024 · 1 indication expansions
Aug 2013 SUPPL
Mfg
Jul 2013 SUPPL
Mfg
What MIRAPEX ER Treats
3 FDA approvalsOriginally approved for its first indication in 2010 . Covers 3 distinct patient populations.
- Other (3)
Boehringer Ingelheim's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00893841 | D1443C00032 | Ph 2 | completed | Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride |
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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.
MIRAPEX ER FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
183 international docs across 43 countries
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 98 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.