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Profile for Tradename: MIRAPEX

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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.

Summary for Tradename: MIRAPEX

Suppliers: see list5

Pharmacology for Tradename: MIRAPEX

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

Clinical Trials for: MIRAPEX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-002Feb 19, 2010RXNo8,679,533<disabled>Y<disabled>
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 2010RXNo7,695,734<disabled>Y<disabled>
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 1997RXNo6,001,861<disabled><disabled>
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997RXNo6,001,861<disabled><disabled>
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET;ORAL020667-003Jul 1, 1997RXNo6,194,445<disabled><disabled>
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Paragraph IV activity for: MIRAPEX

Drugname Dosage Strength RLD Submissiondate
pramipexole dihydrochlorideExtended-release Tablets2.25 mg and 3.75 mgMirapex ER7/26/2011
pramipexole dihydrochlorideExtended-release Tablets0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mgMirapex ER6/1/2010
pramipexole dihydrochlorideTablets0.75 mgMirapex7/31/2008
pramipexole dihydrochlorideTablets0.125 mg, 0.5 mg, 1 mg and 1.5 mgMirapex6/24/2005
pramipexole dihydrochlorideTablets0.25 mgMirapex5/27/2005
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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