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Generic Mirapex ER Availability

See also: Generic Mirapex

Mirapex ER is a brand name of pramipexole, approved by the FDA in the following formulation(s):

MIRAPEX ER (pramipexole dihydrochloride - tablet, extended release;oral)

Has a generic version of Mirapex ER been approved?

A generic version of Mirapex ER 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 ER and have been approved by the FDA:

pramipexole dihydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: April 21, 2016
    Strength(s): 0.375MG [AB], 0.75MG [AB], 1.5MG [AB], 3MG [AB], 4.5MG [AB]
  • Manufacturer: ANCHEN PHARMS
    Approval date: February 6, 2014
    Strength(s): 0.375MG [AB], 0.75MG [AB], 1.5MG [AB], 2.25MG [AB], 3MG [AB], 3.75MG [AB], 4.5MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: August 7, 2015
    Strength(s): 0.375MG [AB], 0.75MG [AB], 1.5MG [AB], 3MG [AB], 4.5MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: June 24, 2016
    Strength(s): 0.375MG [AB], 0.75MG [AB], 1.5MG [AB], 2.25MG [AB], 3MG [AB], 4.5MG [AB]
  • Manufacturer: SANDOZ INC
    Approval date: December 4, 2014
    Strength(s): 0.375MG [AB], 0.75MG [AB], 1.5MG [AB], 3MG [AB], 4.5MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mirapex ER. 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.

  • Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
    Patent 7,695,734
    Issued: April 13, 2010
    Inventor(s): Friedl; Thomas & Eisenreich; Wolfram
    Assignee(s): Boehringer Ingelheim International GmbH
    An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least one water swelling polymer other than pregelatinized starch.
    Patent expiration dates:
    • April 26, 2028
      Drug product
  • Pramipexole once-daily dosage form
    Patent 8,679,533
    Issued: March 25, 2014
    Assignee(s): Pharmacia Corporation
    An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
    Patent expiration dates:
    • September 8, 2029
      Drug product


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.