Even though certain exclusivity rights for Mirapex ER have expired, no generic versions are available yet. Although it's unclear why no generic versions have been introduced, it's likely that the drug is still protected by another patent (that has not yet expired). There are generic versions of short-acting pramipexole available, but these drugs are not equivalent to Mirapex ER.
Mirapex ER is made by Boehringer Ingelheim Pharmaceuticals, Inc. Currently, Mirapex ER is protected by patents that prevent any generic versions from being sold in the United States.
When Will a Generic Version Be Available?
The first patents for Mirapex ER expired in October 2010. Exclusivity rights (which are similar to patents) expired in February 2013 and March 2013. However, the drug appears to be protected by a patent that expires later. There is also a patent for Mirapex ER that does not expire until April 2028. At this point, the next earliest time a generic might possibly become available is April 2028.
Is Pramipexole a Generic Mirapex ER?
No -- pramipexole is the active ingredient in Mirapex ER, but it is not a generic version of it. There are generic versions of short-acting pramipexole available, but these medications are not equivalent to Mirapex ER. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as the "generic name." The generic name is different from a generic version of a medicine.
In order for there to be a generic version of a medicine, the original medicine must have gone off-patent, and another company besides the original manufacturer would make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed March 25, 2013.
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