See also: Generic Mirapex ER
Mirapex is a brand name of pramipexole, approved by the FDA in the following formulation(s):
MIRAPEX (pramipexole dihydrochloride - tablet; oral)
Manufacturer: BOEHRINGER INGELHEIM
Approval date: July 1, 1997
Strength(s): 0.125MG [AB], 0.25MG [RLD][AB], 1.5MG [AB], 1MG [AB]
Manufacturer: BOEHRINGER INGELHEIM
Approval date: February 12, 1998
Strength(s): 0.5MG [AB]
Manufacturer: BOEHRINGER INGELHEIM
Approval date: July 30, 2007
Strength(s): 0.75MG [AB]
Has a generic version of Mirapex been approved?
A generic version of Mirapex has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Mirapex and have been approved by the FDA:
pramipexole dihydrochloride tablet; oral
Manufacturer: ACTAVIS PHARMA
Approval date: November 30, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: ALEMBIC LTD
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: BARR
Approval date: February 19, 2008
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: BRECKENRIDGE PHARM
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: GLENMARK GENERICS
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: MYLAN
Approval date: April 9, 2010
Strength(s): 0.75MG [AB]
Manufacturer: MYLAN
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: SANDOZ
Approval date: July 6, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: SANDOZ
Approval date: October 8, 2010
Strength(s): 0.75MG [AB]
Manufacturer: TEVA PHARMS
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: TORRENT PHARMS
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: WATSON LABS
Approval date: October 8, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Manufacturer: ZYDUS PHARMS USA INC
Approval date: July 6, 2010
Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1.5MG [AB], 1MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mirapex. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Use of pramipexole in the treatment of restless legs syndrome
Patent 6,001,861
Issued: December 14, 1999
Inventor(s): Oertel; Wolfgang H. & Meier; Dieter & Gomez-Mancilla; Baltazar & Montplaisir; Jacques
Assignee(s): Pharmacia & Upjohn Company
The present invention provides the use of pramipexole in the treatment of restless legs syndrome.Patent expiration dates:
- January 16, 2018✓
- January 16, 2018
Use of pramipexole in the treatment of restless legs syndrome
Patent 6,194,445
Issued: February 27, 2001
Inventor(s): Oertel; Wolfgang H. & Meier; Dieter & Gomez-Mancilla; Baltazar & Montplaisir; Jacques
Assignee(s): Pharmacia & Upjohn Company
Boehringer Ingelheim Pharma KG
The present invention provides the use of pramipexole in the treatment of restless legs syndrome.Patent expiration dates:
- January 16, 2018✓
- January 16, 2018
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- May 13, 2014 - INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY
See also...
- Mirapex Consumer Information (Drugs.com)
- Mirapex Consumer Information (Wolters Kluwer)
- Mirapex Consumer Information (Cerner Multum)
- Mirapex Advanced Consumer Information (Micromedex)
- Mirapex AHFS DI Monographs (ASHP)
- Pramipexole Consumer Information (Wolters Kluwer)
- Pramipexole Extended-Release Tablets Consumer Information (Wolters Kluwer)
- Pramipexole Consumer Information (Cerner Multum)
- Pramipexole Advanced Consumer Information (Micromedex)
- Pramipexole Dihydrochloride AHFS DI Monographs (ASHP)
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