Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Mirapex, Mirapex Er. Every FDA application for this active ingredient: 3 branded and 30 generic.
As of Nov 15, 2026, FDA lists 33 applications for Pramipexole Dihydrochloride (sold as Mirapex, Mirapex Er), first approved Jul 1, 1997, with 5 new uses approved and 0 published complete response letters.
First approved: Jul 1, 1997
Applications: 33
New uses approved: 5
Complete response letters: 0
First approved in the EU: Oct 13, 1997
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
PRAMIPEXOLE 0.125 MG TABLET: $0.038 per unitGeneric · -6% in a year
PRAMIPEXOLE 0.25 MG TABLET: $0.043 per unitGeneric · -7% in a year
PRAMIPEXOLE 0.5 MG TABLET: $0.055 per unitGeneric · +2% in a year
PRAMIPEXOLE 0.75 MG TABLET: $0.065 per unitGeneric · -20% in a year
PRAMIPEXOLE 1 MG TABLET: $0.065 per unitGeneric · +5% in a year
PRAMIPEXOLE 1.5 MG TABLET: $0.062 per unitGeneric · -5% in a year
PRAMIPEXOLE ER 0.375 MG TABLET: $0.859 per unitGeneric · -44% in a year
PRAMIPEXOLE ER 0.75 MG TABLET: $0.681 per unitGeneric · -49% in a year
PRAMIPEXOLE ER 1.5 MG TABLET: $1.58 per unitGeneric · -30% in a year
PRAMIPEXOLE ER 2.25 MG TABLET: $1.62 per unitGeneric · -27% in a year
PRAMIPEXOLE ER 3 MG TABLET: $1.53 per unitGeneric · -53% in a year
PRAMIPEXOLE ER 4.5 MG TABLET: $1.73 per unitGeneric · -25% in a year
Mirapex-LA, new approvalDrugs in new dosage forms and with new dosages indicated for the treatment of Parkinson's disease. · Nippon Boehringer Ingelheim Co., Ltd. · Apr 22, 2011
Bi•SifrolDrugs with a new additional indication and a new dosage for the treatment of moderate to severe idiopathic restless legs syndrome. · Nippon Boehringer Ingelheim Co., Ltd. · Jan 20, 2010
Clinical Trials
14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Pramipexole and the Risk of Serious Adverse EventsOlder Adults (65 Years and Older), Chronic Kidney Disease (CKD) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Boehringer Ingelheim
Zydus Pharms USA Inc
Alembic
Sandoz
Sun Pharm Inds Inc
Strides Pharma