Tuesday, September 13, 2016

Mirapex


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
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)




  • 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
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)



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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