Generic Mirapex ER Availability
Last updated on Apr 10, 2025.
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)
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Manufacturer: BOEHRINGER INGELHEIM
Approval date: February 19, 2010
Strength(s): 0.375MG (discontinued) [RLD], 0.75MG (discontinued) [RLD], 1.5MG (discontinued) [RLD], 3MG (discontinued) [RLD], 4.5MG (discontinued) [RLD] -
Manufacturer: BOEHRINGER INGELHEIM
Approval date: June 17, 2011
Strength(s): 2.25MG (discontinued) [RLD], 3.75MG (discontinued) [RLD]
All of the above formulations have been discontinued.
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: Generic Drug FAQ.
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.
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Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
Patent 7,695,734
Issued: April 13, 2010
Inventor(s): Friedl; Thomas et al.
Assignee(s): Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)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✓
- April 26, 2028
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Pramipexole once-daily dosage form
Patent 8,679,533
Issued: March 25, 2014
Inventor(s): Lee Ernest J. & Bredael Gerard M. & Baldwin John R. & Cox Steven R. & Heintz Mark J.
Assignee(s): Pharmacia CorporationAn 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✓✓
- September 8, 2029
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A 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 Exclusivity | Exclusivity 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. |
| RLD | A 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. |
Further information
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