Generic Mirapex Availability

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)

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 GRP PTC
    Approval date: November 30, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: ALEMBIC LTD
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: April 30, 2012
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: October 26, 2012
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: BARR
    Approval date: February 19, 2008
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: BRECKENRIDGE PHARM
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: September 20, 2012
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [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], 1MG [AB], 1.5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: July 6, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: October 8, 2010
    Strength(s): 0.75MG [AB]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: March 27, 2013
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 0.75MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: October 8, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: July 6, 2010
    Strength(s): 0.125MG [AB], 0.25MG [AB], 0.5MG [AB], 1MG [AB], 1.5MG [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

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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