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Generated: September 26, 2017

DrugPatentWatch Database Preview

MIRAPEX ER Drug Profile

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What is the patent landscape for Mirapex Er, and when can generic versions of Mirapex Er launch?

Mirapex Er is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and fourteen patent family members in forty-four countries.

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

Summary for Tradename: MIRAPEX ER

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list48
Clinical Trials: see list22
Patent Applications: see list3,947
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MIRAPEX ER at DailyMed

Pharmacology for Tradename: MIRAPEX ER

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-006Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-002Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-007Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-006Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-002Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: MIRAPEX ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 2010► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 2010► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 2010► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-002Feb 19, 2010► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for MIRAPEX ER

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

Non-Orange Book Patents for Tradename: MIRAPEX ER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,377,977Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof► Subscribe
8,399,016Sustained-release tablet composition of pramipexole► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: MIRAPEX ER

Country Document Number Estimated Expiration
Georgia, Republic ofP20074048► Subscribe
Ukraine80831► Subscribe
Singapore148996► Subscribe
Serbia20050059► Subscribe
Japan2008509194► Subscribe
BrazilPI0513846► Subscribe
Slovenia1781260► Subscribe
Japan2011126916► Subscribe
Taiwan201100126► Subscribe
Australia2003256921► 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 ER

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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
Chinese Patent Office
Cantor Fitzgerald
AstraZeneca
Baxter
Covington
US Army
Colorcon
QuintilesIMS
Merck

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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