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MIRAPEX Drug Profile

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Which patents cover Mirapex, and what substitute generic drugs are available?

Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are four patents protecting this drug and five Paragraph IV challenges.

This drug has thirty-nine patent family members in twenty-five countries.

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Thirty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for Tradename: MIRAPEX

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list5
Bulk Api Vendors: see list131
Clinical Trials: see list9
Patent Applications: see list4,333
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MIRAPEX at DailyMed

Pharmacology for Tradename: MIRAPEX

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997RXYesNo6,001,861► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010RXYesNo8,679,533► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-007Jun 17, 2011RXYesNo8,679,533► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-007Jul 30, 2007RXYesNo6,001,861► Subscribe ► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-002Jul 1, 1997RXYesYes6,194,445► Subscribe ► Subscribe
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Expired Patents for Tradename: MIRAPEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-003Jul 1, 19974,886,812► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 19974,886,812► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 19974,843,086► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-006Feb 12, 19984,886,812► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-007Jul 30, 20074,886,812► Subscribe
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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

International Patent Family for Tradename: MIRAPEX

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9831362► Subscribe
Poland334498► Subscribe
Germany19701619► Subscribe
Japan4406685► Subscribe
Australia6016898► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MIRAPEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/017United Kingdom► SubscribePRODUCT NAME: PRAMIPEXOLE, OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT, IN PARTICULAR PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/97/050/001 19971014; UK EU/1/97/050/002 19971014; UK EU/1/97/050/003 19971014; UK EU/1/97/050/004 19971014; UK EU/1/97/050/005 19971014; UK EU/1/97/050/006 19971014; UK EU/1/97/050/007 19971014; UK EU/1/97/050/008 19971014; UK EU/1/97/050/009 19971014; UK EU/1/97/050/010 19971014
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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