Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from five suppliers. There are four patents protecting this drug and five Paragraph IV challenges.
The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
|Suppliers: see list||5|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET, EXTENDED RELEASE;ORAL||022421||Feb 19, 2010||RX||No||7,695,734||<disabled>||Y||<disabled>|
|TABLET;ORAL||020667||Jul 1, 1997||RX||Yes||6,194,445||<disabled>||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||022421||Feb 19, 2010||RX||Yes||7,695,734||<disabled>||Y||<disabled>|
|TABLET;ORAL||020667||Jul 1, 1997||RX||No||6,001,861||<disabled>||<disabled>|
|TABLET;ORAL||020667||Feb 12, 1998||RX||No||<disabled>||<disabled>|
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|pramipexole dihydrochloride||Extended-release Tablets||2.25 mg and 3.75 mg||Mirapex ER||7/26/2011|
|pramipexole dihydrochloride||Extended-release Tablets||0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg||Mirapex ER||6/1/2010|
|pramipexole dihydrochloride||Tablets||0.75 mg||Mirapex||7/31/2008|
|pramipexole dihydrochloride||Tablets||0.125 mg, 0.5 mg, 1 mg and 1.5 mg||Mirapex||6/24/2005|
|pramipexole dihydrochloride||Tablets||0.25 mg||Mirapex||5/27/2005|
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